FDA Device recall Z-0697-2022
Microbiologics QC Sets and Panels: Helix Elite
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Microbiologics QC Sets and Panels: Helix Elite by Microbiologics, citing real-time shelf life testing failed at 24 months.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0697-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-06 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209
Reason
Real-time shelf life testing failed at 24 months
Identifiers
| code_info | Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2022%22
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