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U.S. Department of Health and Human Services

Class 2 Device Recall ORAcollect RNA

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 Class 2 Device Recall ORAcollect RNAsee related information
Date Initiated by FirmFebruary 18, 2022
Create DateApril 21, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0982-2022
Recall Event ID 89831
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductORAcollect RNA: ORE-100
Code Information 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 2		Nonconforming Material/Component
ActionNotification 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 Commerce17,080 (US: 14, 17,066)
DistributionWorldwide 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 CycleTPLC 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.
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