Recall Z-0955-2022
Microbiologics Inc · initiated March 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Inactivated macrolide-resistant Mycoplasma genitalium
Codes / lots: Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
Reason for recall
The QC process was not adequate for the specification range.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0955-2022
- Initiated
- March 22, 2022
- Terminated
- January 9, 2023
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 2 ea
- Distribution
- US Nationwide distribution in the states of NV and VT.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN