Microbiologics Inactivated Macrolide-Resistant Mycoplasma Genitalium Recall
Microbiologics recalls inactivated macrolide-resistant Mycoplas: QC process failed for specification range. No remedy stated in official notice.
Recall notice
The QC process was not adequate for the specification range.
Contact the company
What happened, in plain English
Microbiologics is recalling a specific strain of Mycoplasma genitalium due to inadequate quality control during production. This means the product may not meet safety standards, though the exact risk is unclear from the recall notice. Read more at govinfonow.com/recall/60905-microbiologics-inactivated-macrolide-resistant-mycoplasma-genitalium-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/60905-microbiologics-inactivated-macrolide-resistant-mycoplasma-genitalium-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0955-2022
Cite this page
“Microbiologics Inactivated Macrolide-Resistant Mycoplasma Genitalium Recall.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60905-microbiologics-inactivated-macrolide-resistant-mycoplasma-genitalium-recall. Based on FDA recall #Z-0955-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0955-2022%22&limit=1).
Why it’s dangerous
The quality control process did not properly check the product against the required specifications. This could mean the product is not safe for intended use, but the exact hazard is not detailed in the recall notice.
Who’s affected
This recall affects laboratory or medical users who have the specific catalog number HE0070N and lot HE0070-01-1. Healthcare professionals handling this product are most at risk.
How to tell if you have this one
Check for the catalog number HE0070N and lot number HE0070-01-1 on the product label. The product is an inactivated macrolide-resistant Mycoplasma genitalium strain.
- Brand
Microbiologics- Category
Medical device
What to do — step by step
Check Product Details
Look for catalog number HE0070N and lot number HE0070-01-1 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of NV and VT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Nevada, Vermont.
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-0955-2022 (March 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0955-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.