Recall Z-0955-2022 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Inactivated macrolide-resistant Mycoplasma genitalium
| Date | Mar 22, 2022 |
| Status | Terminated |
| Reason | The QC process was not adequate for the specification range. |
| Root cause | Process control |
| Action | A customer letter, dated 03/24/2022, was issued to the impacted consignee via email. The consignee is instructed to destroy the product as it is now past its updated expiration date. The consignee is asked to complete the response form and submit to the recalling firm. |
| Quantity | 2 ea |
| Distribution | US Nationwide distribution in the states of NV and VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.