Helix Elite" Molecular Standards: Inactivated Standard — Class II medical device recall Z-0699-2022
Terminated recall by Microbiologics Inc, reported 2022-03-09, distributed nationwide. Real-time shelf life testing failed at 24 months
| Recall number | Z-0699-2022 |
|---|---|
| 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 | 1 units |
| UPC / GTIN / UDI-DI | 10845357042023 |
| Lot numbers | HE0028N-102-1 |
| Model numbers | HE0028N |
Product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.
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-0699-2022. 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.