CLASS II Device recall · Reported 27 Apr 2022 · FDA Enforcement Report
Inactivated macrolide-resistant Mycoplasma genitalium recalled
Microbiologics is recalling Inactivated macrolide-resistant Mycoplasma genitalium, distributed nationwide in the US. The recall was initiated on 22 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0955-2022
- FDA event ID
- 89887
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2022
- FDA classified
- 19 Apr 2022
- Reported
- 27 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2022 | Recall initiated by company | |
| 19 Apr 2022 | Classified by FDA | +28 days |
| 27 Apr 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The QC process was not adequate for the specification range.
Product as listed by the FDA
Inactivated macrolide-resistant Mycoplasma genitalium
Where it was distributed
US Nationwide distribution in the states of NV and VT.
Questions about this recall
Why was it recalled?
The QC process was not adequate for the specification range.
Which lots are affected?
Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
Where was it sold?
US Nationwide distribution in the states of NV and VT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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