Recall record at a glance
| Official record | Z-0847-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | VISBY MEDICAL Inc. |
| Report date | Jan 20, 2021 |
| Recall initiation date | Dec 5, 2020 |
| Quantity | Total = 282 kits |
| Location | San Jose, CA, United States |
Official product description
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.
Why the product 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.
Distribution information
U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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