Z-0955-2022Class II

Inactivated macrolide-resistant Mycoplasma genitalium

Name: Z-0955-2022 Inactivated macrolide-resistant Mycoplasma genitalium
Creator: Microbiologics Inc
Published: 2022-03-22
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2022-03-22 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Inactivated macrolide-resistant Mycoplasma genitalium on 2022-03-22. FDA classified it as Class II and gives the reason as "The QC process was not adequate for the specification range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0955-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-22
Posted: 2022-04-19
Terminated: 2023-01-09
Recalling firm: Microbiologics, Inc.
Product: Inactivated macrolide-resistant Mycoplasma genitalium
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: The QC process was not adequate for the specification range.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2 ea
Distribution: US Nationwide distribution in the states of NV and VT.
Product codes and lots: Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0955-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-19

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)