FDA Device recall Z-0847-2021
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical C…
- FDA Device
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical C… by Visby Medical, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0847-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-05 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Visby Medical |
| Distribution | US |
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 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
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.
Identifiers
| code_info | Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.