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.
Other recalls by Microbiologics
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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-0699-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.