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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Becton Dickinson & Co.: BD BBL Sensi Discs Recalled for Inaccurate Antibiotic Susceptibility Testing

Agency Publication Date: February 8, 2024
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Summary

Becton Dickinson & Co. is recalling approximately 70.8 million BD BBL Sensi Disc units used for antibiotic susceptibility testing due to a risk of inaccurate results. These discs are used by laboratory professionals to determine which antibiotics are effective against H. influenzae bacteria; however, failures in testing accuracy and quality control have been identified. Incorrect results can lead to delayed diagnoses, the selection of inappropriate antibiotics for patients, or extended treatment times. If you have been treated for an infection where these diagnostic tests were used, contact your healthcare provider to discuss your treatment history.

Risk

The recalled testing discs may produce inaccurate or failed results when testing H. influenzae, which could lead doctors to prescribe the wrong antibiotic or delay effective treatment for serious infections. This risk of diagnostic error can prolong a patient's illness or lead to adverse medical outcomes due to improper antibiotic exposure.

What You Should Do

  1. Identify if your facility has any of the 30 affected Sensi Disc products, such as Amoxicillin, Ampicillin, Azithromycin, or Ciprofloxacin, by checking the Catalog Number, UDI-DI, and Lot Number on the product packaging.
  2. Check for specific affected lots such as Sensi Disc Amoxicillin Catalog No. 231628 (Lots 2090490, 2146520, 2210201, 2276143, 3062095) or BD BBL Sensi Disc Ampicillin Catalog No. 230705 (Lots 1301474, 1334111, 2025840, 2146318, 2242344, 2276051, 2333100, 3150355, 3234179).
  3. Laboratory professionals should immediately stop using the affected lots for H. influenzae susceptibility testing and follow the manufacturer's instructions regarding product discard or validation.
  4. If you are a patient and are concerned about previous diagnostic results involving these discs, contact your healthcare provider or physician to review your treatment plan.
  5. Healthcare facilities should contact Becton Dickinson & Co. at the contact information provided in the firm's notification letter for further technical instructions or to facilitate a potential refund or replacement.
  6. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Validation or discard of product based on diagnostic outcomes

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Sensi Disc Amoxicillin with Clavulanic Acid 20/10 µg
Model / REF:
Catalog No. 231628
Catalog No. 231629
UPC Codes:
00382902316282
30382902316290
Lot Numbers:
2090490
2146520
2210201
2276143
3062095
3163306
3163307
3163310
3254307
3254309
3271840
3271853
2146526
2147225
2224295
2276144
3003894
3090649
Product: BD BBL Sensi Disc Ampicillin - 10 µg / 2 µg
Model / REF:
Catalog No. 230705
Catalog No. 231264
Catalog No. 231263
UPC Codes:
00382902307051
30382902312643
30382902312636
Lot Numbers:
1301474
1334111
2025840
2146318
2242344
2276051
2333100
3150355
3234179
3030225
3058510
3282314
2003260
3010977
3058508
3184064
3234190
1302042
2003517
2146414
2243865
2277199
2339360
Product: BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 µg
Model / REF:
Catalog Number 231660
UPC Codes:
30382902316603
Lot Numbers:
3010074
3093387
3163062
3223403
3234193
2063349
2119619
2276123
Product: BD BBL Sensi Disc Azithromycin - 15 µg
Model / REF:
Catalog Number 231682
UPC Codes:
30382902316825
Lot Numbers:
3093408
3163065
2004501
2147712
2304517
Product: BD BBL Sensi Disc Aztreonam - 30 µg
Model / REF:
Catalog Number 231640
Catalog Number 231641
UPC Codes:
00382902316404
30382902316412
Lot Numbers:
1117192
1211613
1243750
1278287
3214945
2304491
3093375
3184116
3261101
3282901
1305148
2004458
2028924
2090502
2244457
Product: BD BBL Sensi Disc Cefaclor - 30 µg
Model / REF:
Catalog Number 231653
UPC Codes:
30382902316535
Lot Numbers:
1085898
1273095
1273096
2004485
2147706
2333108
Product: BD BBL Sensi Disc Cefepime - 30 µg
Model / REF:
Catalog Number 231696
UPC Codes:
30382902316962
Lot Numbers:
2339439
3118297
3163524
3223410
3243084
3282873
2063393
2119624
2119625
2119626
2147720
2213567
2273732
Product: BD BBL Sensi Disc Cefixime - 5 µg
Model / REF:
Catalog Number 231664
UPC Codes:
30382902316641
Lot Numbers:
2004492
3010077
3223406
1305984
2091014
Product: BD BBL Sensi Disc Cefotaxime - 30 µg / 5 µg
Model / REF:
Catalog Number 231606
Catalog Number 231607
Catalog Number 291308
UPC Codes:
00382902316060
30382902316078
Lot Numbers:
2004580
2025164
2090467
2146516
2180432
2301360
3003886
3062270
3158078
3261093
2301468
3003046
3093596
3116037
3248537
3248540
Product: BD BBL Sensi Disc Cefpodoxime - 10 µg
Model / REF:
Catalog Number 231673
Catalog Number 231674
UPC Codes:
00382902316732
30382902316740
Lot Numbers:
3109152
3157106
3241174
Product: BD BBL Sensi Disc Ceftaroline - 30 µg
Model / REF:
Catalog Number 232231
UPC Codes:
30382902322314
Lot Numbers:
3116030
3212690
Product: BD BBL Sensi Disc Ceftazidime - 30 µg
Model / REF:
Catalog Number 231632
Catalog Number 231633
UPC Codes:
00382902316329
30382902316337
Lot Numbers:
2004587
2028883
2119589
2146527
2242568
2301371
3118111
3181037
3062286
3223389
3290192
2028232
2028894
2056528
Product: BD BBL Sensi Disc Ceftriaxone - 30 µg
Model / REF:
Catalog Number 231634
Catalog Number 231635
UPC Codes:
00382902316343
30382902316351
Lot Numbers:
1033870
1244758
2026381
2056573
2277488
3062288
3158099
3254299
0344489
1088039
1116107
1148606
1180379
1211608
1335697
2028922
2180451
2277490
Product: BD BBL Sensi Disc Cefuroxime - 30 µg
Model / REF:
Catalog Number 231621
UPC Codes:
30382902316214
Lot Numbers:
2304487
3093372
3158087
3223379
1335657
2004439
2090487
2147701
2210631
Product: BD BBL Sensi Disc Chloramphenicol - 30 µg
Model / REF:
Catalog Number 230733
Catalog Number 231274
UPC Codes:
00382902307334
30382902312742
Lot Numbers:
1020750
1116997
1180198
1211448
1277739
1301482
1334126
2025900
2063283
2210054
2277205
3003821
3129527
3263117
9336993
0080290
0178844
0258758
0057245
1057453
1148461
Product: BD BBL Sensi Disc Ciprofloxacin - 5 µg
Model / REF:
Catalog Number 231657
Catalog Number 231658
UPC Codes:
00382902316572
30382902316580
Lot Numbers:
1060926
1279842
2028533
2091948
2301402
3214964
3248370
1335458
2336475
3062295
3093427
3163048
0344330
1007112
1127037
1335457
2028547
2091980
2336474
Product: BD BBL Sensi Disc Clarithromycin - 15 µg
Model / REF:
Catalog Number 231678
UPC Codes:
30382902316788
Lot Numbers:
1305187
2119623
2339435
3129541
Product: BD BBL Sensi Disc Doripenem - 15 µg
Model / REF:
Catalog Number 232219
UPC Codes:
30382902322192
Lot Numbers:
3040749
3093444
3163515
3296612
Product: BD BBL Sensi Disc Ertapenem - 10 µg
Model / REF:
Catalog Number 232174
Catalog Number 232175
UPC Codes:
00382902321743
30382902321751
Lot Numbers:
1301766
1341479
2119610
2147329
2242618
2276113
2333166
3152004
3181140
2333175
2119612
Product: BD BBL Sensi Disc Imipenem - 10 µg
Model / REF:
Catalog Number 231644
Catalog Number 231645
UPC Codes:
00382902316442
30382902316450
Lot Numbers:
1335006
2056580
2091918
2210318
2301385
3062101
3094134
3118125
3214950
3261103
2081151
2091925
2147704
2210343
2277500
Product: BD BBL Sensi Disc Levofloxacin - 5 µg
Model / REF:
Catalog Number 231705
Catalog Number 231706
UPC Codes:
00382902317050
30382902317068
Lot Numbers:
1334510
2004644
2091272
2277179
3030830
3094117
3248344
3184118
2213599
Product: BD BBL Sensi Disc Meropenem - 10 µg
Model / REF:
Catalog Number 231703
Catalog Number 231704
UPC Codes:
00382902317036
30382902317044
Lot Numbers:
2147649
9065664
2213585
3061281
3090652
3213825
2187975
2213583
Product: BD BBL Sensi Disc Minocycline - 30 µg
Model / REF:
Catalog Number 231250
Catalog Number 231251
UPC Codes:
00382902312505
30382902312513
Lot Numbers:
1085656
1277053
1301694
1334451
2025108
2119580
2146396
3181025
1007140
3234149
1210753
Product: BD BBL Sensi Disc Moxifloxacin - 5 µg
Model / REF:
Catalog Number 231758
UPC Codes:
30382902317587
Lot Numbers:
3003061
3243078
1305255
2119637
2153502
2301547
Product: BD BBL Sensi Disc Ofloxacin - 5 µg
Model / REF:
Catalog Number 231672
UPC Codes:
30382902316726
Lot Numbers:
1305177
2039254
2180484
2304476
Product: BD BBL Sensi Disc Piperacillin/Tazobactam - 100/10 µg
Model / REF:
Catalog Number 231691
Catalog Number 231692
UPC Codes:
00382902316916
30382902316924
Lot Numbers:
1301719
2026369
2056587
2119595
3003951
3062107
3118199
3275730
3184117
3223408
2147716
2244463
Product: BD BBL Sensi Disc Rifampin - 5 µg
Model / REF:
Catalog Number 231541
Catalog Number 231544
UPC Codes:
00382902315414
30382902315446
Lot Numbers:
1278110
1334479
2004554
2025125
2056466
2242510
3214931
1116055
1211489
2339407
3030278
3158059
0343413
1032232
1088790
1148547
2090443
Product: BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 µg
Model / REF:
Catalog Number 231536
Catalog Number 231539
UPC Codes:
00382902315360
30382902315392
Lot Numbers:
1060689
1116935
1210905
1242939
1306103
1334461
2004540
2025116
2056456
2108378
2146453
2301307
3003869
3062089
3094151
3118079
3152968
3248444
0309595
0343394
2339393
3214768
3282335
1148543
2277321
Product: BD BBL Sensi Disc Tetracycline 30 µg
Model / REF:
Catalog Number 230998
Catalog Number 231344
UPC Codes:
00382902309987
30382902313442
Lot Numbers:
1242880
1277918
1301570
2025088
2056233
2118569
2276681
3094187
3212760
3263267
9009914
9046895
0065366
0178210
3010027
3062263
3158029
3275644
0085202
0230453
0274792
0335906
1095603
1148539
1180271
2089874
8355562
9130797
9239639
9263061

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93789
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Authorized Medical Distributors; Becton Dickinson direct sales
Manufactured In: United States
Units Affected: 30 products (2,363,168 total units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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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.