Recall Z-1740-2022 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
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
| Date | Sep 14, 2022 (initiated Jul 27, 2022) |
| Status | Terminated |
| Reason | Product not registered for use in the UK |
| Root cause | Process control |
| Action | Microbiologics initially contacted the consignee via email on 07/27/2022. A formal letter was provided via email on 08/15/2022. The notification instructed the consignee to review lab procedures to understand how the recall affects their usage, discard any units depending on the lab procedures, complete and return the response form, maintain the recall letter for record, and contact Microbiologics for replacement if needed. |
| Quantity | 2 |
| Distribution | International distribution to the country of United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.