visby medical COVID-19 Test kit *** An in vitro diagnostic for the… — Class II medical device recall Z-0847-2021
Terminated recall by VISBY MEDICAL INC, reported 2021-01-20, distributed nationwide. Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA
| Recall number | Z-0847-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VISBY MEDICAL INC, San Jose, CA, United States |
| Recall initiated | 2020-12-05 |
| Classified | 2021-01-12 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2022-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 282 kits |
| Reason classes | labeling |
| Lot numbers | LN20100067, LN20100148, LN20110040, LN20110213, WR20100003 |
| Model numbers | PS-001442 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0847-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.