FDA Device recall Z-1139-2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC…
- FDA Device
- Class II
- ongoing
- Published 2024-02-21
On 2024-02-21 the FDA classified a Class II recall of BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC… by Biofire Diagnostics, citing due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1139-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-26 |
| Published | 2024-02-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Reason
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
Identifiers
| code_info | For BioFire Blood Culture Identification 2 (BDID2) Panel Part Number: RFIT-ASY-0147 UDI-DI code: 00815381020338 Lot Num…For BioFire Blood Culture Identification 2 (BDID2) Panel Part Number: RFIT-ASY-0147 UDI-DI code: 00815381020338 Lot Numbers: All non-expired BCID2 Panel lots, if used with the BD BACTEC vials including but not limited to, the bottle types listed in Table 1. NOTE: The affected blood culture vial types most likely contain non-viable Candida tropicalis nucleic acid/DNA fragments that can be detected by the BCID2 Panel. Therefore, all lots of the BioFire BCID2 Panel would be affected if they are used with the affected blood culture vials. Neither the BioFire BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1139-2024%22
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