Blood Culture Identification Panel May Produce False Positive Results
The BIOFIRE BCID2 Panel may produce false positive Serratia marcescens results when used with certain culture media bottles, potentially leading to inappropriate changes in patient therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall of a diagnostic test that may produce false positive results for Serratia marcescens identification. No illnesses, injuries, or deaths have been reported in the source material. The hazard represents a risk-of-harm scenario—potential for inappropriate patient therapy changes—without reported actual harm, meeting the High severity criteria.
Plain-English summary
The FDA is recalling the BIOFIRE Blood Culture Identification 2 (BCID2) Panel, manufactured by BioFire Diagnostics, LLC. Approximately 99,822 units have been distributed worldwide.
When the BCID2 Panel is used with specific lots of BACT/ALERT culture media bottles, it may produce false positive identification results for Serratia marcescens. The false positives occur due to an increased level of non-viable organisms from Serratia marcescens present in affected culture media bottles.
False positive results could lead clinicians to make inappropriate changes to a patient's therapy. Healthcare facilities and laboratories using affected batches should review their inventory and contact BioFire Diagnostics for remediation guidance.
The recalled product
- 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
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 99,822
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 (13)
- BCID2 Panel REF: RFIT-ASY-0147
- UDI-DI: 00815381020338
- 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
Distribution
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