FDA Device recall Z-1392-2023
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) by Biofire Diagnostics, citing due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1392-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-08 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Reason
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Identifiers
| code_info | Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109 |
|---|
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-1392-2023%22
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