GS Biomark recalls CoViPoint COVID test kits without FDA approval. Affected kits include specific item and lot numbers. Consumers should stop using these kits immediately.
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
GS Biomark is recalling CoViPoint COVID test kits that were distributed without FDA approval. This means the kits may not be safe or reliable for use, and users should stop using them immediately.
These test kits were distributed without FDA approval, meaning they may not be safe or reliable. Using them could lead to inaccurate results or potential health risks if the test is not properly validated.
Anyone who owns or uses the recalled CoViPoint COVID test kits. People who have the specific item or lot numbers listed in the recall are most at risk.
Check the item numbers on the kit: BC-DK0200, BM-AD4K0200, BM-ADK0200, BM-CDK0200, BM-CFDK0200, and other listed numbers. Also check the lot numbers provided for each item.
Discard any CoViPoint COVID test kits with the listed item or lot numbers to avoid potential inaccuracies or health risks.
The kits were distributed without FDA approval, which means they may not be safe or reliable for use.
The affected item numbers include BC-DK0200, BM-AD4K0200, BM-ADK0200, BM-CDK0200, BM-CFDK0200, and other specific numbers listed in the recall.
The recall does not mention a return process; the remedy is null, so you should discard the kits immediately.
We’ve drafted a message you can send GS Biomark to request your refund or repair — edit it as you like.
Subject: Recall Z-0324-2023 — GS Biomark GS Biomark Hello, I own a GS Biomark that is covered by recall Z-0324-2023 from GS Biomark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
