BioFire recalls FilmArray BCID Panel (RFIT-ASY-0126) used with specific BACT/ALERT blood culture bottles. False positive Proteus results may cause improper antibiotic treatment. Affected units have UDI: 00815381020086.
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
BioFire is recalling FilmArray BCID Panels used with certain BACT/ALERT blood culture bottles. False positive Proteus test results could lead to patients getting the wrong antibiotics for up to 48 hours.
The test can produce false positive results for Proteus bacteria when used with certain blood culture bottles. This may cause doctors to give the wrong antibiotics for up to 48 hours while waiting for actual test results.
Healthcare providers using the FilmArray BCID Panel with specific BACT/ALERT blood culture bottles are affected. Patients receiving antibiotic treatment based on these tests may be at risk of improper treatment.
Check if your FilmArray BCID Panel has the UDI code 00815381020086 and was used with BACT/ALERT blood culture bottles (410851, 410852, 410853, or 259790). The product was sold with expiration dates from September 19, 2020 onward.
Look for the UDI code 00815381020086 on the FilmArray BCID Panel.
Confirm you used the panel with BACT/ALERT blood culture bottles with catalog numbers 410851, 410852, 410853, or 259790.
The FilmArray BCID Panel can produce false positive Proteus results when used with specific blood culture bottles, which may lead to patients receiving improper antibiotic treatment for up to 48 hours.
The recall record does not specify a remedy or action steps for affected users.
BACT/ALERT blood culture bottles with catalog numbers 410851, 410852, 410853, or 259790.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2295-2020 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2295-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
