FDA Device recall Z-0699-2022
Helix Elite" Molecular Standards: Inactivated Standard
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Helix Elite" Molecular Standards: Inactivated Standard by Microbiologics, citing real-time shelf life testing failed at 24 months.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0699-2022 |
| 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
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
Real-time shelf life testing failed at 24 months
Identifiers
| code_info | Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023 |
|---|
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-0699-2022%22
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