Blood Culture Identification Test Recalled Due to False Positive Risk
BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in 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: This Class II FDA recall involves a diagnostic test with false positive results that could affect patient treatment decisions. Although no illnesses or injuries have been reported, this meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
BioFire Diagnostics, LLC is recalling 14,140 BioFire Blood Culture Identification 2 (BCID2) Panel kits distributed in the United States (11,155 kits) and internationally (2,985 kits). The recall affects all lots of the BCID2 Panel (Part Number RFIT-ASY-0147, UDI: 00815381020338) and associated blood culture media vials with expiration dates of April 30, 2022 or earlier.
The recall is due to an increased risk of false positive results for Acinetobacter calcoaceticus-baumannii complex organisms. Non-viable contamination in the blood culture vials is the identified cause. False positive test results could lead to incorrect organism identification and potentially inappropriate treatment decisions.
The affected products have been distributed to healthcare facilities across all U.S. states and to multiple countries worldwide.
The recalled product
- Product
- BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic…
- Manufacturer
- BioFire Diagnostics, LLC
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)
- 2022 or earlier.
Distribution
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