BioFire FilmArray Blood Culture Kit False Positive Risk with Specific Bottles
BioFire Diagnostics recalls FilmArray Blood Culture Identification kits that may give false positive results for Proteus when used with certain blood culture bottles. Affected kits include specific catalog numbers and bottle types.
Lower-risk recall
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling some FilmArray Blood Culture Identification kits because they can produce false positive results for Proteus when used with specific blood culture bottles. This could lead to incorrect diagnoses and unnecessary treatments. Read more at govinfonow.com/recall/69909-biofire-filmarray-blood-culture-kit-false-positive-risk-with-specific.
Source Summary by GovInfoNow · govinfonow.com/recall/69909-biofire-filmarray-blood-culture-kit-false-positive-risk-with-specific · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0296-2019
Cite this page
“BioFire FilmArray Blood Culture Kit False Positive Risk with Specific Bottles.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69909-biofire-filmarray-blood-culture-kit-false-positive-risk-with-specific. Based on FDA recall #Z-0296-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0296-2019%22&limit=1).
Why it’s dangerous
The FilmArray kits can give false positive results for Proteus bacteria when used with specific blood culture bottles (BACT/ALERT FA Plus, FN Plus, or PF Plus). This means tests might incorrectly indicate Proteus infection when there isn't one, potentially leading to unnecessary treatments.
Who’s affected
Healthcare facilities using the recalled FilmArray Blood Culture Identification kits with the listed blood culture bottles are most at risk. Patients receiving blood cultures with these kits may be affected if the false positive results lead to incorrect treatment.
How to tell if you have this one
Check if your FilmArray Blood Culture Identification kit has catalog numbers RFIT-ASY-0126 (30 tests) or RFIT-ASY-0127 (6 tests). Also, verify if you're using the BACT/ALERT FA Plus (410851), FN Plus (410852), or PF Plus (410853) blood culture bottles.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Kit Catalog Number
Identify if your FilmArray Blood Culture Identification kit has catalog numbers RFIT-ASY-0126 (30 test kit) or RFIT-ASY-0127 (6 test kit).
Verify Blood Culture Bottles
Confirm if you're using BACT/ALERT FA Plus (410851), FN Plus (410852), or PF Plus (410853) blood culture bottles.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the kits immediately?
No, but you should check if your kit and bottles match the recalled items before using them. The recall does not require immediate discontinuation.
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Where this comes from
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.
- Official source: FDA Recall #Z-0296-2019 (September 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0296-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.