visby medical COVID-19 Test kit *** An in vitro recall: Labeling Error
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19…
Why was visby medical COVID-19 Test kit *** An in vitro 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)
- Product
- visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19…
- Recalling firm
- VISBY MEDICAL INC
- Quantity
- Total = 282 kits
- Distribution
- U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)