FDA Device recall Z-0451-2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray…
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray… by Biofire Diagnostics, citing routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0451-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-17 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251
Reason
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.
Identifiers
| code_info | REF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior. |
|---|
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-0451-2024%22
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