FDA Device recall Z-2456-2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Medi…
- FDA Device
- Class II
- ongoing
- Published 2024-08-07
On 2024-08-07 the FDA classified a Class II recall of BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Medi… by Biofire Diagnostics, citing if blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an incr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2456-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-19 |
| Published | 2024-08-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
Reason
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
Identifiers
| code_info | BCID2 Panel REF: RFIT-ASY-0147, UDI-DI: 00815381020338, All unexpired lots. BACT/ALERT REF/UDI-DI: Lot/Expiration: 41…BCID2 Panel REF: RFIT-ASY-0147, UDI-DI: 00815381020338, All unexpired lots. BACT/ALERT REF/UDI-DI: Lot/Expiration: 410851/03573026596057: 0004101638/3/20/2024, 0004101930/7/28/2024, 0004102026/9/4/2024, 0004102408/2/16/2025, 0004102996/9/24/2025, 0004102946/8/29/2025, 0004102956/9/17/2025, 0004102998/9/24/2025. 410853/03573026596095: 0004101718/4/24/2024, 0004101790/6/1/2024, 0004101958/8/3/2024, 0004102452/3/3/2025, 0004102964/9/19/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Biofire Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2456-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.