FDA Device recall Z-1903-2021
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (0…
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (0… by Biofire Diagnostics, citing elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1903-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-10 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Reason
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
Identifiers
| code_info | Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338 |
|---|
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-1903-2021%22
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