BioFire FilmArray BCID Panel Recall: False Positive Proteus Risk with BD BACTEC Bottles
BioFire Diagnostics recalls FilmArray BCID Blood Culture Panels with specific BD BACTEC bottles, risking false Proteus results. Affected units include catalog numbers RFIT-ASY-0126 and RFIT-ASY-0127 with certain bottle lots.
Lower-risk recall
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
Contact the company
What happened, in plain English
BioFire Diagnostics recalls FilmArray BCID Blood Culture Identification Panels that may give false positive Proteus results when used with specific BD BACTEC blood culture bottles. This could lead to incorrect infection diagnoses if the test is not properly interpreted. Read more at govinfonow.com/recall/71721-biofire-filmarray-bcid-panel-recall-false-positive-proteus-risk-with.
Source Summary by GovInfoNow · govinfonow.com/recall/71721-biofire-filmarray-bcid-panel-recall-false-positive-proteus-risk-with · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1513-2018
Cite this page
“BioFire FilmArray BCID Panel Recall: False Positive Proteus Risk with BD BACTEC Bottles.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71721-biofire-filmarray-bcid-panel-recall-false-positive-proteus-risk-with. Based on FDA recall #Z-1513-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1513-2018%22&limit=1).
Why it’s dangerous
The FilmArray BCID Panel can produce false positive Proteus results when paired with certain BD BACTEC blood culture bottles. This means the test might incorrectly indicate a Proteus infection when none exists, potentially leading to unnecessary treatments or missed infections.
Who’s affected
Healthcare facilities using the FilmArray BCID Panel with the listed BD BACTEC blood culture bottles are most at risk. Patients receiving blood culture tests with these specific combinations may see inaccurate results.
How to tell if you have this one
Check if your FilmArray BCID Panel has catalog numbers RFIT-ASY-0126 (30 tests) or RFIT-ASY-0127 (6 tests). Also verify if you're using BD BACTEC blood culture bottles with catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, or 442191.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Panel Catalog Number
Identify if your FilmArray BCID Panel is catalog number RFIT-ASY-0126 (30 tests) or RFIT-ASY-0127 (6 tests).
Verify Bottle Lot Numbers
Confirm if your BD BACTEC blood culture bottles have catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, or 442191.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican…” 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 7 months 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
What should I do if I have the recalled product?
The recall does not include a remedy; you should check if your panel and bottles match the listed catalog numbers to determine if you need to switch to a different bottle type.
Are there any specific expiration dates for the bottles?
Yes, the BD BACTEC Blood Culture Bottles have expiration dates of 9/30/2018 and beyond.
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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-1513-2018 (March 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1513-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 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.