Reported Jan 20, 2021 · Terminated
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage:…
Visby Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VISBY MEDICAL INC · 3010 N 1st St · San Jose, CA · 95134-2023
Is this the product you have?
- visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative
- detection of SARS-CoV-2 - Product UsageThe Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization
- Lot codes and dates
- Part NumberPS-001442
- Lot NumbersLN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)
- Amount recalled
- Total = 282 kits
Where it was sold
Why it was recalled
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.
This product could cause temporary or reversible health problems — stop using it.
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