FDA Device recall Z-0954-2022
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
- FDA Device
- Class II
- terminated
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Inactivated macrolide and quinolone-resistant Mycoplasma genitalium by Microbiologics, citing QC process was not adequate for the specification range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0954-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-24 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Reason
QC process was not adequate for the specification range.
Identifiers
| code_info | Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Microbiologics
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2022%22
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