BioFire recalls BCID2 Panel (REF RFIT-ASY-0147) due to potential false negatives in blood culture tests. Affected units have pouches with wrong packaging material. Contact for remedy.
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
BioFire is recalling its BCID2 Blood Culture Identification Panel because some units have pouches made with the wrong packaging material, which can cause false negative results in blood culture tests. This means the test might incorrectly show no infection when one exists.
The panel uses pouches that contain the wrong packaging material (OPP) instead of the correct type. This manufacturing issue can cause the test to give false negative results, meaning infections might be missed.
Healthcare professionals using the BioFire BCID2 Panel for blood culture tests are most at risk. The recall affects specific units with incorrect pouch packaging.
Check for the product code REF RFIT-ASY-0147 on the panel. Look for pouch lot number 11YA20 and kit lot number 2039020. The unique device identifier (UDI) is (01)00815381020338.
Verify the product code REF RFIT-ASY-0147, pouch lot number 11YA20, and kit lot number 2039020 on the panel.
The panel has pouches made with the wrong packaging material (OPP) instead of the correct type, which can cause false negative results in blood culture tests.
Check for the product code REF RFIT-ASY-0147, pouch lot number 11YA20, and kit lot number 2039020 on the panel. The unique device identifier (UDI) is (01)00815381020338.
The recall does not specify a remedy, so contact BioFire Diagnostics for further instructions.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-1903-2021 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-1903-2021 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.
