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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

DNA Genotek Inc.: Evaporation of stabilizing liquid reducing shelf life.

Agency Publication Date: April 21, 2022
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Affected Products

Product: ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

627595000309 01006275950003091722091210XI512, Lot XI512 627595000309 01006275950003091722091310XI513, Lot XI513 627595000309 01006275950003091722091410XI514, Lot XI514 627595000309 01006275950003091722091610XI519, Lot XI519 627595000309 01006275950003091722091610XI520, Lot XI520 627595000309 01006275950003091722091710XI521, Lot XI521 627595000309 01006275950003091722091810XI522, Lot XI522 627595000309 01006275950003091722093010XI534, Lot XI534 627595000309 01006275950003091722102810XJ536, Lot XJ536 627595000309 01006275950003091722102810XJ537, Lot XJ537 627595000309 01006275950003091722111510XK518, Lot XK518 627595000309 01006275950003091722111610XK519, Lot XK519 627595000309 01006275950003091722120310XL503, Lot XL503 627595000309 01006275950003091722120310XL506, Lot XL506 627595000309 01006275950003091722120410XL510, Lot XL510 627595000309 01006275950003091722120510XL511, Lot XL511 627595000309 01006275950003091722120610XL512, Lot XL512 627595000309 01006275950003091722121410XL521, Lot XL521 627595000309 01006275950003091722121510XL522, Lot XL522 627595000309 01006275950003091722123110XL535, Lot XL535 627595000309 01006275950003091723010410YA501, Lot YA501 627595000309 01006275950003091723011110YA510, Lot YA510 627595000309 01006275950003091723011510YA515, Lot YA515 627595000309 01006275950003091723011610YA516, Lot YA516 627595000309 01006275950003091723013010YA531, Lot YA531 627595000309 01006275950003091723013110YA532, Lot YA532 627595000309 01006275950003091723021510YB522, Lot YB522 627595000309 01006275950003091723021610YB523, Lot YB523 627595000309 01006275950003091723022610YB534, Lot YB534 627595000309 01006275950003091723031910YC525, Lot YC525 627595000309 01006275950003091723032010YC526, Lot YC526 627595000309 01006275950003091723032110YC527, Lot YC527 627595000309 01006275950003091723032510YC532, Lot YC532 627595000309 01006275950003091723032610YC533, Lot YC533 627595000309 01006275950003091723041210YD512, Lot YD512 627595000309 01006275950003091723041310YD513, Lot YD513 627595000309 01006275950003091723050710YE510, Lot YE510 627595000309 01006275950003091723050810YE511, Lot YE511 627595000309 01006275950003091723050910YE512, Lot YE512 627595000309 01006275950003091723051010YE513, Lot YE513 627595000309 01006275950003091723051110YE514, Lot YE514 627595000309 01006275950003091723051310YE516, Lot YE516 627595000309 01006275950003091723051410YE518, Lot YE518 627595000309 01006275950003091723051410YE519, Lot YE519 627595000309 01006275950003091723051510YE520, Lot YE520 627595000309 01006275950003091723051610YE521, Lot YE521 627595000309 01006275950003091723051710YE522, Lot YE522 627595000309 01006275950003091723051810YE523, Lot YE523 627595000309 01006275950003091723052610YE533, Lot YE533 627595000309 01006275950003091723052710YE534, Lot YE534 627595000309 01006275950003091723060210YF503, Lot YF503 627595000309 01006275950003091723060610YF507, Lot YF507 627595000309 01006275950003091723061010YF512, Lot YF512 627595000309 01006275950003091723061110YF513, Lot YF513 627595000309 01006275950003091723061210YF514, Lot YF514 627595000309 01006275950003091723061310YF515, Lot YF515 627595000309 01006275950003091723061410YF516, Lot YF516 627595000309 01006275950003091723061510YF517, Lot YF517 627595000309 01006275950003091723061610YF518, Lot YF518 627595000309 01006275950003091723062110YF523, Lot YF523 627595000309 01006275950003091723062210YF524, Lot YF524 627595000309 01006275950003091723072810YG532, Lot YG532 627595000309 01006275950003091723072910YG533, Lot YG533 627595000309 01006275950003091723073010YG534, Lot YG534 627595000309 01006275950003091723081010YH511, Lot YH511 627595000309 01006275950003091723081210YH517, Lot YH517 627595000309 01006275950003091723081610YH521, Lot YH521 627595000309 01006275950003091723081710YH522, Lot YH522 627595000309 01006275950003091723090410YI504, Lot YI504 627595000309 01006275950003091723090510YI505, Lot YI505 627595000309 01006275950003091723090610YI506, Lot YI506 627595000309 01006275950003091723090710YI508, Lot YI508 627595000309 01006275950003091723100910YJ513, Lot YJ513 627595000309 01006275950003091723101010YJ514, Lot YJ514 627595000309 01006275950003091723101110YJ515, Lot YJ515 627595000309 01006275950003091723101610YJ522, Lot YJ522 627595000309 01006275950003091723101710YJ523, Lot YJ523 627595000309 01006275950003091723101810YJ524, Lot YJ524 627595000309 01006275950003091723102010YJ527, Lot YJ527 627595000309 01006275950003091723102110YJ529, Lot YJ529 627595000309 01006275950003091723110110YK101, Lot YK101 627595000309 01006275950003091723111110YK113, Lot YK113 627595000309 01006275950003091723111810YK117, Lot YK117 627595000309 01006275950003091724010310ZA100, Lot ZA100 627595000309 01006275950003091724010410ZA101, Lot ZA101 627595000309 01006275950003091724010510ZA102, Lot ZA102 627595000309 01006275950003091724012410ZA113, Lot ZA113 627595000309 01006275950003091722110510XK505, Lot XK505 627595000309 01006275950003091723013010YA530, Lot YA530 627595000309 01006275950003091723061010YF511, Lot YF511 627595000309 01006275950003091723090710YI507, Lot YI507 627595000309 01006275950003091723110110YK100, Lot YK100 627595000309 01006275950003091724012810ZA120, Lot ZA120 627595000309 01006275950003091723020510YB506, Lot YB506 627595000309 01006275950003091723101910YJ526, Lot YJ526 627595000309 01006275950003091722120310XL504, Lot XL504 627595000309 01006275950003091722120310XL505, Lot XL505 627595000309 01006275950003091723111110YK112, Lot YK112 627595000309 01006275950003091723040710YD507, Lot YD507 627595000309 01006275950003091723041610YD516, Lot YD516 627595000309 01006275950003091723041710YD517, Lot YD517 627595000309 01006275950003091723041910YD520, Lot YD520 627595000309 01006275950003091723080910YH509, Lot YH509 627595000309 01006275950003091723080910YH510, Lot YH510 627595000309 01006275950003091723083010YH540, Lot YH540 627595000309 01006275950003091723120610YL106, Lot YL106 627595000309 01006275950003091723120810YL108, Lot YL108 627595000309 01006275950003091723010610YA503, Lot YA503 627595000309 01006275950003091723011110YA509, Lot YA509 627595000309 01006275950003091723011210YA511, Lot YA511 627595000309 01006275950003091723011510YA514, Lot YA514 627595000309 01006275950003091723020910YB511, Lot YB511 627595000309 01006275950003091723021010YB512, Lot YB512 627595000309 01006275950003091723022410YB531, Lot YB531 627595000309 01006275950003091723032210YC529, Lot YC529 627595000309 01006275950003091723032310YC530, Lot YC530 627595000309 01006275950003091723040110YD501, Lot YD501 627595000309 01006275950003091723040210YD502, Lot YD502 627595000309 01006275950003091723060410YF505, Lot YF505 627595000309 01006275950003091723060510YF506, Lot YF506 627595000309 01006275950003091723070210YG502, Lot YG502 627595000309 01006275950003091723070510YG506, Lot YG506 627595000309 01006275950003091723072610YG530, Lot YG530 627595000309 01006275950003091723072710YG531, Lot YG531 627595000309 01006275950003091723080310YH503, Lot YH503 627595000309 01006275950003091723080410YH504, Lot YH504 627595000309 01006275950003091723080510YH505, Lot YH505 627595000309 01006275950003091723082410YH533, Lot YH533 627595000309 01006275950003091723082510YH534, Lot YH534 627595000309 01006275950003091723082610YH535, Lot YH535 627595000309 01006275950003091723082710YH536, Lot YH536 627595000309 01006275950003091723090810YI509, Lot YI509 627595000309 01006275950003091723100410YJ504, Lot YJ504 627595000309 01006275950003091723100510YJ505, Lot YJ505 627595000309 01006275950003091723100610YJ506, Lot YJ506 627595000309 01006275950003091723110210YK102, Lot YK102 627595000309 01006275950003091723110310YK103, Lot YK103 627595000309 01006275950003091723112610YK125, Lot YK125 627595000309 01006275950003091723120710YL107, Lot YL107 627595000309 01006275950003091723120910YL109, Lot YL109 627595000309 01006275950003091723121010YL113, Lot YL113 627595000309 01006275950003091723121110YL115, Lot YL115 627595000309 01006275950003091723121310YL116, Lot YL116 627595000309 01006275950003091723121610YL120, Lot YL120 627595000309 01006275950003091723121710YL121, Lot YL121 627595000309 01006275950003091723121810YL122, Lot YL122 627595000309 01006275950003091723122010YL125, Lot YL125 627595000309 01006275950003091723020110YB501, Lot YB501 627595000309 01006275950003091723060110YF502, Lot YF502 627595000309 01006275950003091723092010YI525, Lot YI525 627595000569 01006275950005691723102210YJ530, Lot YJ530

Lot Numbers (151):
XI512
XI513
XI514
XI519
XI520
XI521
XI522
XI534
XJ536
XJ537
XK518
XK519
XL503
XL506
XL510
XL511
XL512
XL521
XL522
XL535
YA501
YA510
YA515
YA516
YA531
YA532
YB522
YB523
YB534
YC525
YC526
YC527
YC532
YC533
YD512
YD513
YE510
YE511
YE512
YE513
YE514
YE516
YE518
YE519
YE520
YE521
YE522
YE523
YE533
YE534
Product: ORAcollect RNA: ORE-100

Lot: YJ530

Lot Numbers:
YJ530

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89831
Status: Active
Manufacturer: DNA Genotek Inc.
Manufactured In: Canada
Units Affected: 2 products (2,375,514 (US: 2,148,222 OUS: 227,292); 17,080 (US: 14, 17,066))

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

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.