Microbiologics Inc Recall 90761
Description: Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Microbiologics Inc Recall 90761 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1740-2022 |
| Event ID | 90761 |
| Event Description | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N |
| Product Type | Devices |
| Distribution | International distribution to the country of United Kingdom. |
| Quantity | 2 |
| Recall Reason | Product not registered for use in the UK |
| Device Classification | 20220921 |
| Device Code Info | a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023. |
| Center Classification Date | 20220916 |
| Recall Initiation Date | 20220727 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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