FDA Device recall Z-1451-2020
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
- FDA Device
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only by Biofire Diagnostics, citing complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1451-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-08 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biofire Diagnostics |
| Distribution | IL, KY, MS, NJ |
Product
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Reason
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Identifiers
| code_info | Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Biofire Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1451-2020%22
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