CoViPoint COVID Test Kits Distributed Without FDA Approval or Clearance
GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device distributed without FDA approval or clearance. As an unapproved diagnostic device, it constitutes a risk-of-harm product. The source material does not report any illnesses or injuries, so the severity is 3 per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Approximately 639,200 CoViPoint COVID test kits (MultiPLEX/Direct) manufactured by GS Biomark LLC were distributed without required FDA approval, clearance, or authorization. These kits were distributed to healthcare facilities and distributors across multiple US states including Texas, New York, Georgia, Indiana, Maryland, California, Pennsylvania, Washington, D.C., New Jersey, Oregon, and Washington.
The recall was initiated because the test kits were distributed without obtaining FDA approval, clearance, or emergency use authorization. This means the FDA had not evaluated whether these test kits are safe and effective for their intended use.
The recalled product
- Product
- 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
- Manufacturer
- GS Biomark LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- lack-of-fda-clearance
- diagnostic-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 110121005
- 72021004
- 81021003
- 92721002
- 102521003
- 112221002
- 30122001 BM-DK0200 / 51821001
- 71221002
- 72021003
- 72721001
- 80521001
- 80921003
- 81021002
- 90721003
- 90721004
- 90921003
- 102521002
- 111521002
- 22422002 BM-DK0600 / 110521002
- 10722003
Distribution
Distributed in 11 states:
- CA
- DC
- GA
- IN
- MD
- NJ
- NY
- OR
- PA
- TX
- WA
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