Is 1 Step 12 Panel Cup, Item No. NBCA-12M-W recalled?

Low RiskFDA Device

Ameditech Inc: Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.; Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specif

Agency Publication Date: December 24, 2015

Affected Products

Product: 1 Step 12 Panel Cup, Item No. NBCA-12M-W

143107 151657 153155 153529

Product: 10-Panel Pipette Drug Screen, Item No. PSP-10M

153135 154119

Product: 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA

153632

Product: 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

144376

Product: 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

151688 152423 153307 153912 153921 153961 153962 154104 154112 154236 154264

Product: 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

G140255-C G140422-C G150063-C G150184-C G150211-C G150226-C G150240-C G150286-C

Product: BZO Strip Dip Card (300ng/ml)*, Item No. 100170

141233 141669 141790 141820 141958 142082 142531 142532 142835 143020 143471 143553 152021 152432 152546 153094 153538 152104

Product: CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

142709 142840 143008 143571 143665 144217 152234 152379

Product: DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

143235 144216 151591 153132 153489

Product: DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D

143978 144485 151982 153095

Product: DrugSmart 11 Test Cup, Item No. 61127D

144196 144375 150096 151980 152737

Product: DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

152736 143864 150204 151981

Product: DrugSmart 9 Test Cup (BUP), Item No. 60960D

144029 152738

Product: DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D

143516 143977 150397 152070 152751

Product: DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

150309

Product: DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D

142122 142699 143170

Product: DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

142141 143169

Product: EDI BZO Uncut Sheet - Cup*, Item No. 160170

141260 141294 141909 141925 142074 142243 142428 142614 142712 142911 144555 151925 152003 152223 152498 152723 152897 153311 153559 153818 154184 152103

Product: iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

143037 143106 144152 144218 152456 152457 152698 153048 153129 153201 153385 153648

Product: iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

152459 152823

Product: iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

143345 143442 151537 152163 152334 152674 152697 153075 153127 153216 153390 153499 153634

Product: iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

141900 142194 142959 144377 151998 152740 152993 153229 153363 153544

Product: iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650

Product: Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5

143846 144380 150312 150505 153177 153488

Product: Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP

144103

Product: Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

141758 141921 142657 143178 143581 144563 151337 152240 152782 153154 153401

Product: Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP

143847 144565 150313 152169 152338

Product: ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3

144009 144078 144099 144125 144193 144268 152996 153077

Product: ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P

143861 144204 144263

Product: Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

143937 144574 145061

Product: Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

G140256 G140281 G140307 G140340 G140418 G140419 G150135 G150141 G150187 G150257

Product: ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX

152164 153134

Product: ProScreen 10 Panel Cup, Item No. PSCup-10M

142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651 151706 152165 152167 152168 153102 153107 153251 153411 153412 153633

Product: ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM

144240 150059

Product: ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300

141963 142196 143166 143475 143827 152038 152172 152218 152323 152393 152394 152870 153362

Product: ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

144902 150474 151686 151687 152043 152225 152312 152402 152952 153306 153563 153663 153664 153665 153680 153682 153703 153704 153759 153760 153763 153852 153853

Product: ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

142986 143352 151745 152170 153262

Product: ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M

142570 144104

Product: ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

152401

Product: ProScreen 5 Panel Dip Card, Item No. PSD-12BUP

141953 151770 151771 153522

Product: ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300

152912

Product: ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU

G150179

Product: ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

G140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307

Product: ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

141955 142043 142055 142161 142513 142600 142824 142937 142938 142969 143143 143149 143234 143513 143758 143806 143807 144441 152035 152042 152075 152911 153237 153240 153523

Product: ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

G150001 G150244 G150293

Product: ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3

152112 152705 153400

Product: ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M

142059 143006 143570 152175 153524

Product: ProScreen 8 Panel Dip Card, Item No. PSD-8P

152305 152306 153503

Product: ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

152950 152951 153325

Product: ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

152950 152951 153325

Product: ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300

G150252

Product: ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W

141906 143153 143803 150003 150207 150650 151786 152081

Product: ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

141779 142656 142963 143874 144562 151996

Product: ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W

142964 150790 151707

Product: ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W

152171 152216 153103

Product: ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

142153 142594 143825 144227 152005 152972

Product: RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA

153709

Product: THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU

G150189 G150271 G150299

Product: THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU

G150328

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72651

Status: Resolved

Manufacturer: Ameditech Inc

Manufactured In: United States

Units Affected: 58 products (1,377 kits; 240 kits; 40 kits; 50 kits; 858 kits; 3,603 kits; 31,472 kits; 10,320 kits; 1,907 kits; 340 kits; 320 kits; 160 kits; 320 kits; 272 units; 60 kits; 120 kits; 80 units; 45,584 kits; 6,304 kits; 26 units; 9,566 kits; 2,085 kits; 8,290 units; 320 kits; 240 kits; 1,909 kits; 200 kits; 2,693 kits; 60 kits; 144 kits; 4,646 kits; 160 kits; 3,411 kits; 96 kits; 2,452 kits; 1,989 kits; 636 kits; 1200 kits; 60 kits; 338 kits; 120 kits; 60 kits; 7,805 kits; 2,675 kits; 168 kits; 200 kits; 567 kits; 249 kits; 82 kits; 3 kits; 2,136 kits; 492 kits; 129 kits; 1,680 kits; 743 kits; 80 kits; 300 kits; 100 kits)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 1 Step 12 Panel Cup, Item No. NBCA-12M-W

143107 151657 153155 153529

Product: 10-Panel Pipette Drug Screen, Item No. PSP-10M

153135 154119

Product: 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA

153632

Product: 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

144376

Product: 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

151688 152423 153307 153912 153921 153961 153962 154104 154112 154236 154264

Product: 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

G140255-C G140422-C G150063-C G150184-C G150211-C G150226-C G150240-C G150286-C

Product: BZO Strip Dip Card (300ng/ml)*, Item No. 100170

141233 141669 141790 141820 141958 142082 142531 142532 142835 143020 143471 143553 152021 152432 152546 153094 153538 152104

Product: CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

142709 142840 143008 143571 143665 144217 152234 152379

Product: DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

143235 144216 151591 153132 153489

Product: DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D

143978 144485 151982 153095

Product: DrugSmart 11 Test Cup, Item No. 61127D

144196 144375 150096 151980 152737

Product: DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

152736 143864 150204 151981

Product: DrugSmart 9 Test Cup (BUP), Item No. 60960D

144029 152738

Product: DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D

143516 143977 150397 152070 152751

Product: DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

150309

Product: DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D

142122 142699 143170

Product: DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

142141 143169

Product: EDI BZO Uncut Sheet - Cup*, Item No. 160170

141260 141294 141909 141925 142074 142243 142428 142614 142712 142911 144555 151925 152003 152223 152498 152723 152897 153311 153559 153818 154184 152103

Product: iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

143037 143106 144152 144218 152456 152457 152698 153048 153129 153201 153385 153648

Product: iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

152459 152823

Product: iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

143345 143442 151537 152163 152334 152674 152697 153075 153127 153216 153390 153499 153634

Product: iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

141900 142194 142959 144377 151998 152740 152993 153229 153363 153544

Product: iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650

Product: Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5

143846 144380 150312 150505 153177 153488

Product: Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP

144103

Product: Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

141758 141921 142657 143178 143581 144563 151337 152240 152782 153154 153401

Product: Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP

143847 144565 150313 152169 152338

Product: ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3

144009 144078 144099 144125 144193 144268 152996 153077

Product: ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P

143861 144204 144263

Product: Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

143937 144574 145061

Product: Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

G140256 G140281 G140307 G140340 G140418 G140419 G150135 G150141 G150187 G150257

Product: ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX

152164 153134

Product: ProScreen 10 Panel Cup, Item No. PSCup-10M

142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651 151706 152165 152167 152168 153102 153107 153251 153411 153412 153633

Product: ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM

144240 150059

Product: ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300

141963 142196 143166 143475 143827 152038 152172 152218 152323 152393 152394 152870 153362

144902 150474 151686 151687 152043 152225 152312 152402 152952 153306 153563 153663 153664 153665 153680 153682 153703 153704 153759 153760 153763 153852 153853

Product: ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

142986 143352 151745 152170 153262

Product: ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M

142570 144104

Product: ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

152401

Product: ProScreen 5 Panel Dip Card, Item No. PSD-12BUP

141953 151770 151771 153522

Product: ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300

152912

Product: ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU

G150179

Product: ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

G140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307

Product: ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

141955 142043 142055 142161 142513 142600 142824 142937 142938 142969 143143 143149 143234 143513 143758 143806 143807 144441 152035 152042 152075 152911 153237 153240 153523

Product: ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

G150001 G150244 G150293

Product: ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3

152112 152705 153400

Product: ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M

142059 143006 143570 152175 153524

Product: ProScreen 8 Panel Dip Card, Item No. PSD-8P

152305 152306 153503

Product: ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

152950 152951 153325

Product: ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

152950 152951 153325

Product: ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300

G150252

Product: ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W

141906 143153 143803 150003 150207 150650 151786 152081

Product: ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

141779 142656 142963 143874 144562 151996

Product: ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W

142964 150790 151707

Product: ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W

152171 152216 153103

Product: ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

142153 142594 143825 144227 152005 152972

Product: RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA

153709

Product: THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU

G150189 G150271 G150299

Product: THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU

G150328

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72651

Status: Resolved

Manufacturer: Ameditech Inc

Manufactured In: United States