Recall Z-0954-2022
Microbiologics Inc · initiated March 24, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Codes / lots: Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990
Reason for recall
QC process was not adequate for the specification range.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0954-2022
- Initiated
- March 24, 2022
- Terminated
- January 9, 2023
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 1 ea
- Distribution
- US Nationwide distribution in the state of TX.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN