BioFire FilmArray BCID Panel Recall: False Positive Risk with Blood Culture Bottles
BioFire Diagnostics recalls FilmArray BCID Panels that may cause false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. Affected units include certain model numbers and lots.
Lower-risk recall
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling FilmArray BCID Panels that can produce false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. This could lead to incorrect diagnoses if the panels are used with the affected bottles. Read more at govinfonow.com/recall/68896-biofire-filmarray-bcid-panel-recall-false-positive-risk-with-blood.
Source Summary by GovInfoNow · govinfonow.com/recall/68896-biofire-filmarray-bcid-panel-recall-false-positive-risk-with-blood · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1133-2019
Cite this page
“BioFire FilmArray BCID Panel Recall: False Positive Risk with Blood Culture Bottles.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68896-biofire-filmarray-bcid-panel-recall-false-positive-risk-with-blood. Based on FDA recall #Z-1133-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1133-2019%22&limit=1).
Why it’s dangerous
The FilmArray BCID Panels can give false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. This means lab tests might incorrectly indicate bacterial infections, potentially leading to inappropriate treatments.
Who’s affected
Healthcare professionals using the FilmArray BCID Panels with the listed blood culture bottles are most at risk. Patients receiving lab tests using these panels may be affected if the false positives lead to incorrect treatment.
How to tell if you have this one
Check if you have FilmArray BCID Panels with reference numbers RFIT-ASY-0126 or RFIT-ASY-0127. Look for blood culture bottles with part numbers 410851, 410852, or 410853 and the listed lot numbers.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Panel Lot Numbers
Verify if your FilmArray BCID Panel has reference numbers RFIT-ASY-0126 or RFIT-ASY-0127.
Check Blood Culture Bottles
Ensure your blood culture bottles are not part numbers 410851, 410852, or 410853 with the listed lot numbers.
Where it went and when
Where it was distributed
Distributed in 48 states and D.C..
FDA distribution: “MA, NH, VT, CT, NJ, NY, PA, DE, DC, VA, MD, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, AK, BM” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3.5 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.
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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-1133-2019 (March 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1133-2019 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.