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U.S. Department of Health and Human Services

Class 2 Device Recall CoViPoint COVID test kit (MultiPLEX/Direct)

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 Class 2 Device Recall CoViPoint COVID test kit (MultiPLEX/Direct)see related information
Date Initiated by FirmAugust 08, 2022
Date PostedNovember 29, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0324-2023
Recall Event ID 91032
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductCoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
Code Information CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers / Lot Numbers: BC-DK0200 / 42821005 BM-AD4K0200 / 110421005, 110121005, 62322004 BM-ADK0200 / 110121003 BM-CDK0200 / 110121004 BM-CFDK0200 / 110121006 BM-D4K0200 / 71221003, 72021004, 81021003, 92721002, 102521003, 112221002, 30122001 BM-DK0200 / 51821001, 71221002, 72021003, 72721001, 80521001, 80921003, 81021002, 90721003, 90721004, 90921003, 90921003, 90921003, 102521002, 111521002, 22422002 BM-DK0600 / 110521002, 10722003, 12122004 BM-DK0800 / 12722006 BM-DK1200 / 120221002, 50222002 BM-DK1400 / 92421002, 101821005, 32222004 BM-DK1800 / 92321001, 92421001, 101821004, 110521001, 112321001, 120221001, 10722002, 12122002, 12722005, 32222003, 50222001, 60622001, 62922001
Recalling Firm/
Manufacturer		 GS Biomark LLC
1120 116th Ave NE, Suite 102
Bellevue WA 98004
For Additional Information ContactStacie Nelson
888-339-0600
Manufacturer Reason
for Recall		Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
FDA Determined
Cause 2		No Marketing Application
ActionOn 08/08/2022, GS Biomark emailed customer to notify them that their COVID test kits - CoViPoint COVID test kit (MultiPLEX/Direct) have expired and to destroy unused material that they still have on-hand. Customer were not informed that the affected products did not have Emergency Use Authorization to distributed the product within the U.S.
Quantity in Commerce639,200 kits
DistributionU.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
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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