Mycoplasma Genitalium (Microbiologics) – QC process issue (2022)
Quality control process may not meet adequate specification range.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog HE0069N, Lot HE0069-02-1 UDI: 10845357043990
Products Sold
Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990
Microbiologics Inc is recalling Inactivated macrolide and quinolone-resistant Mycoplasma genitalium due to QC process was not adequate for the specification range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
QC process was not adequate for the specification range.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026