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-resistant Mycoplasma genitalium
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog # HE0070N, Lot HE0070-01-1 UDI: 10845357044003
Products Sold
Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
Microbiologics Inc is recalling Inactivated macrolide-resistant Mycoplasma genitalium due to The 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
The QC process was not adequate for the specification range.
Recommended Action
Per FDA guidance
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.
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