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U.S. Department of Health and Human Services

Class 2 Device Recall ORAcollect Dx

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  Class 2 Device Recall ORAcollect Dx see related information
Date Initiated by Firm February 18, 2022
Create Date April 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0981-2022
Recall Event ID 89831
510(K)Number K152464  
Product Classification DNA specimen collection, saliva - Product Code OYJ
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
Code Information 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 
Recalling Firm/
DNA Genotek Inc.
3000-500 Palladium Dr
Kanata Canada
Manufacturer Reason
for Recall
Evaporation of stabilizing liquid reducing shelf life.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Notification emailed to customers 2/18/2022. The shelf-life "Collect sample by/Use by" date found on the collection device tube label has been reduced by 12 months. Contact firm if unable to recover the minimum input volume required for sample extraction. Submit online acknowledgement form and contact your DNA Genotek Account manager or Technical Services with questions: support@dnagenotek.com.
Quantity in Commerce 2,375,514 (US: 2,148,222 OUS: 227,292)
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OYJ and Original Applicant = DNA GENOTEK INC.