BioFire recalls FILMARRAY GI Panel software versions before FLM2-SFW-0040 v2.0.3.1 that may cause false positive Cryptosporidium results. Affected units include specific model numbers and serial ranges.
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
BioFire is recalling certain FILMARRAY Gastrointestinal Panel software versions that could produce false positive Cryptosporidium test results. This means users might get incorrect infection results, which could lead to unnecessary treatment or missed health risks.
The software versions before FLM2-SFW-0040 v2.0.3.1 may cause the test to incorrectly show Cryptosporidium infection when it's not present. This could lead to false positive results that might affect patient care decisions.
Users of the FILMARRAY GI Panel with specific model numbers and software versions prior to FLM2-SFW-0040 v2.0.3.1 are affected. Laboratory staff and healthcare providers using these panels for Cryptosporidium testing are most at risk.
Check for model numbers RFIT-ASY-0104 or RFIT-ASY-0116 with serial numbers starting with 00815381020116 or 00815381020109. The software version must be older than FLM2-SFW-0040 v2.0.3.1 or BFS0001-5539 v2.0.200.10.
Install the latest software version FLM2-SFW-0040 v2.0.3.1 or BFS0001-5539 v2.0.200.10 to fix the false positive issue.
Software versions prior to FLM2-SFW-0040 v2.0.3.1 or BFS0001-5539 v2.0.200.10 are affected.
Check the model number and serial number on your panel. Affected units have model numbers RFIT-ASY-0104 or RFIT-ASY-0116 with specific serial ranges.
No, but you must update the software to the latest version to avoid false positive results.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2588-2023 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2588-2023 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.
