FDA Device recall Z-1253-2023
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 by Biofire Diagnostics, citing due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-01 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Reason
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Identifiers
| code_info | Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2023%22
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