BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results
BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm diagnostic test product. False positive blood culture results could lead to unnecessary antifungal treatment, but no actual illnesses or injuries have been reported. The score reflects risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling all non-expired BIOFIRE Blood Culture Identification 2 (BCID2) Panel lots when used with affected BD BACTEC blood culture vials. The BCID2 Panel is a multiplex nucleic acid assay used to identify microorganisms and resistance markers from positive blood cultures.
The recall is due to false positive results for Candida tropicalis. The affected BD BACTEC vials contain non-viable Candida tropicalis nucleic acid and DNA fragments that are detected by the BCID2 Panel, resulting in false positive identifications even when the organism is not actually present in the patient's blood sample.
The recalled panels have been distributed worldwide, including throughout the United States. Approximately 32,910 panels have been affected. The affected product has the part number RFIT-ASY-0147 and UDI-DI code 00815381020338.
Healthcare providers and laboratories currently using the affected BCID2 panels with BD BACTEC vials should be aware of the potential for false positive Candida tropicalis results. Laboratories should consider retesting of previous results or consulting clinical guidance for appropriate patient management. Neither the BCID2 test kits nor the BD BACTEC vials have defects; both products are performing as designed, but the combination produces unreliable results for Candida tropicalis identification.
The recalled product
- 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 BIO
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-positive-detection
- diagnostic-inaccuracy
- candida-tropicalis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- if used with the BD BACTEC vials including but not limited to
Distribution
Distributed nationwide across the United States.
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