Microbiologics QC Sets and Panels: Helix Elite — Class II medical device recall Z-0697-2022
Terminated recall by Microbiologics Inc, reported 2022-03-09, distributed nationwide. Real-time shelf life testing failed at 24 months
| Recall number | Z-0697-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2017-06-06 |
| Classified | 2022-03-01 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, GB, IN |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 70845357041240 |
| Lot numbers | 8191-01 |
| Model numbers | 8191 |
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 for recall
Real-time shelf life testing failed at 24 months
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0697-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.