BioFire BCID2 Panel Recalled for False Positive Pseudomonas Results
BioFire Diagnostics is recalling BCID2 Panels due to a risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC blood culture vials.
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: The recall is classified as FDA Class II. The hazard involves a risk of false positive results for a pathogen, which poses a risk of harm through incorrect clinical decision-making, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioFire Diagnostics, LLC is recalling 5,220 kits of the BioFire BCID2 Panel (Part No: RFIT-ASY-0147). The recall affects all non-expired lots of the BCID and BCID2 Panels that are used in conjunction with specific BD BACTEC blood culture vials (Catalog No. 442023 and 442020). The product is intended for use with FilmArray systems and is classified as an In Vitro Diagnostic (IVD) requiring a prescription.
The recall was initiated because the firm identified an increased risk of false positive results for Pseudomonas aeruginosa when the BCID/BCID2 Panels are used with the specified BD BACTEC blood culture vials. This issue could lead to incorrect clinical interpretations of blood culture results.
The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Healthcare providers and laboratories should stop using the affected panels with the specified BD BACTEC vials and contact BioFire Diagnostics for further instructions or replacement.
The recalled product
- Product
- BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 5,220
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 (2)
- All non-expired BCID and BCID2 Panel lots
- if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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