VISBY MEDICAL INC Recall 87049
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.
VISBY MEDICAL INC Recall 87049 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0847-2021 |
| Event ID | 87049 |
| Event 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None |
| Quantity | Total = 282 kits |
| Recall 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. |
| Device Classification | 20210120 |
| Device Code Info | Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677) |
| Center Classification Date | 20210112 |
| Recall Initiation Date | 20201205 |
| Recalling Firm | VISBY MEDICAL INC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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