BioFire Diagnostics recalls BCID2 Blood Culture Panel REF RFIT-ASY-0147 with Maine Molecular Quality Controls control panels. Affected units may show C. tropicalis as 'Not Detected' due to assay errors. Contact for remedy.
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.
BioFire Diagnostics is recalling a specific blood culture identification panel that may show false negative results for C. tropicalis infections. This could lead to missed diagnoses if the control panel isn't properly calibrated.
The control panel may cause the test to report C. tropicalis as 'Not Detected' when it's actually present. This happens because the assay's temperature threshold for detection is outside the acceptable range during some test runs.
Healthcare facilities using the BioFire BCID2 Panel with Maine Molecular Quality Controls M416 control panels are affected. Labs using the specific reference number RFIT-ASY-0147 are most at risk.
Check for the BioFire BCID2 Panel reference number RFIT-ASY-0147 on the product label. The affected control panel is the Maine Molecular Quality Controls M416 (FLM1-PRT-0251) used with this panel.
Verify the BioFire BCID2 Panel has reference number RFIT-ASY-0147 on its label.
The control panel may cause C. tropicalis infections to be reported as 'Not Detected' due to assay temperature issues, potentially leading to missed diagnoses.
Check the panel's reference number. If it's RFIT-ASY-0147, contact BioFire Diagnostics for guidance.
The recall record does not specify a remedy, so contact BioFire Diagnostics directly for assistance.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-0451-2024 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-0451-2024 from BioFire. 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.
