BioFire Diagnostics recalls BCID2 Blood Culture Panel when used with specific BD BACTEC vials due to false positive Candida tropicalis results. Affected units may show incorrect fungal detection.
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
BioFire Diagnostics recalls its BCID2 Blood Culture Identification Panel when used with certain BD BACTEC vials. This can cause false positive Candida tropicalis results, potentially leading to incorrect treatment decisions.
The BCID2 Panel may detect non-viable Candida tropicalis DNA fragments in blood culture vials, causing false positive results. This could lead to unnecessary antifungal treatment or delayed proper treatment for actual infections.
Healthcare professionals using the BCID2 Panel with the listed BD BACTEC vials are most at risk. Patients receiving blood culture tests with these combinations could be misdiagnosed.
Check if you have the BCID2 Panel used with BD BACTEC Lytic Anaerobic, Peds, Plus Aerobic, Plus Anaerobic, Standard Aerobic, or Standard Anaerobic vials. The recall affects all non-expired BCID2 Panel lots when used with these vial types.
Verify if your BCID2 Panel is used with the listed BD BACTEC vial types.
The BCID2 Panel may detect non-viable Candida tropicalis DNA fragments in blood culture vials, causing false positive results.
Neither the BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended.
Check if your BCID2 Panel is used with BD BACTEC Lytic Anaerobic, Peds, Plus Aerobic, Plus Anaerobic, Standard Aerobic, or Standard Anaerobic vials.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1139-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1139-2024 from BioFire Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
