Recall Z-0324-2023 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
GS Biomark LLC
CoViPoint 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
| Date | Nov 29, 2022 (initiated Aug 8, 2022) |
| Status | Open, Classified |
| Reason | Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization. |
| Root cause | No Marketing Application |
| Action | On 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 | 639,200 kits |
| Distribution | U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.