Recall Z-0954-2022 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
| Date | Mar 24, 2022 |
| Status | Terminated |
| Reason | QC process was not adequate for the specification range. |
| Root cause | Process control |
| Action | A customer letter, dated 03/24/2022, was emailed to the impacted consignee. 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 | 1 ea |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.