Microbiologics Inactivated Mycoplasma genitalium Recall: QC Process Issue
Microbiolog: Inactivated macrolide and quinolone-resistant Mycoplasma genitalium (HE0069N) recalled due to inadequate QC process. No remedy specified in official notice.
Recall notice
QC process was not adequate for the specification range.
Contact the company
What happened, in plain English
Microbiologics Inc recalled a specific strain of Mycoplasma genitalium (HE0069N) because their quality control process didn't meet specifications. This recall doesn't include a remedy or action for consumers. Read more at govinfonow.com/recall/60896-microbiologics-inactivated-mycoplasma-genitalium-recall-qc-process-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/60896-microbiologics-inactivated-mycoplasma-genitalium-recall-qc-process-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0954-2022
Cite this page
“Microbiologics Inactivated Mycoplasma genitalium Recall: QC Process Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60896-microbiologics-inactivated-mycoplasma-genitalium-recall-qc-process-issue. Based on FDA recall #Z-0954-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2022%22&limit=1).
Why it’s dangerous
The quality control process for this product was inadequate, meaning the product may not meet the required specifications. This could lead to potential issues with the product's effectiveness or safety in medical use.
Who’s affected
This recall affects laboratory or medical users who have the specific Mycoplasma genitalium strain with catalog number HE0069N. Medical professionals handling this product are most at risk.
How to tell if you have this one
Check for the catalog number HE0069N on the product label. The lot number HE0069-02-1 is also associated with this recall. This product is used in medical settings.
- Brand
Microbiologics- Category
Medical device
What to do — step by step
Check Product Details
Look for the catalog number HE0069N and lot number HE0069-02-1 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0954-2022 (March 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0954-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.