Class 2 Device Recall ORAcollect Dx

• Date Initiated by Firm: February 18, 2022
• Create Date: April 21, 2022
• Recall Status: Open, 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 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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, 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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, 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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/ Manufacturer: DNA Genotek Inc.; 3000-500 Palladium Dr; Kanata Canada
• Manufacturer Reason for Recall: Evaporation of stabilizing liquid reducing shelf life.
• FDA Determined Cause: 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