BioFire Diagnostics recalls specific FilmArray Meningitis/Encephalitis panels due to potential false positives for HSV-1. Affected kits may require replacement to avoid incorrect test results.
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) panels that could produce false positive results for HSV-1. This means the test might incorrectly indicate a herpes virus infection when none exists, which could lead to unnecessary treatments or anxiety.
The recall is for kits manufactured with a potential issue in the manufacturing process that could cause the test to show a false positive for HSV-1. This means the test might incorrectly indicate a herpes virus infection when none is present, leading to unnecessary medical actions.
Healthcare providers using the FilmArray ME Panel for diagnostic testing are most at risk. Patients who receive test results from these specific kits may experience unnecessary anxiety or treatment.
Check for the outer kit box with part number RFIT-LBL-0140 and panel reference RFIT-ASY-0118. The kit lot number on the box should be 580818 or 584418, and the expiration date is before April 5, 2019.
Look for the lot number on the outer kit box, which should be 580818 or 584418 for affected kits.
If you have the affected kit, contact BioFire Diagnostics for instructions on how to return or replace it.
BioFire identified a manufacturing issue that might cause false positive results for HSV-1 when using the ME Panel.
If you have the affected kits, they might show a false positive for HSV-1, which could lead to unnecessary treatments or anxiety.
Check the outer kit box for part number RFIT-LBL-0140 and panel reference RFIT-ASY-0118. The lot number should be 580818 or 584418 with an expiration date before April 5, 2019.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0446-2019 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-0446-2019 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.
