FDA Device

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

Hazard

QC process was not adequate for the specification range.

What You Should Do

Remedy

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.

Products

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Brand
Microbiologics Inc
UPC
Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990

Units Affected

1 ea