Recall Z-0847-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
VISBY MEDICAL INC
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 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
| Date | Dec 5, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | On or about 12/07/2020, the firm contacted via telephone its customers and sent an "URGENT *** Recall and Field Corrective Action" Notification Letter via overnight courier informing them of the two issues pertaining to 5 specific lots of their test kits. The issues are: 1) Expiration Date: Visby COVID-19 Test kits lots LN20100067, LN20100148, LN20110040, have an expiration date on the outer kit boxes that matches the expiration date of the Visby COVID-19 devices contained in the foil pouch test kits. However, the outer kit boxes also contains Visby Dilution Kits with a shorter expiration dat |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.