BioFire FILMARRAY GI Panel Software Recall: False Cryptosporidium Results Risk
BioFire recalls FILMARRAY GI Panel software versions before FLM2-SFW-0040 v2.0.3.1 that may cause false positive Cryptosporidium results. Affected units include specific model numbers and serial ranges.
Lower-risk recall
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
Contact the company
What happened, in plain English
BioFire is recalling certain FILMARRAY Gastrointestinal Panel software versions that could produce false positive Cryptosporidium test results. This means users might get incorrect infection results, which could lead to unnecessary treatment or missed health risks. Read more at govinfonow.com/recall/58498-biofire-filmarray-gi-panel-software-recall-false-cryptosporidium-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/58498-biofire-filmarray-gi-panel-software-recall-false-cryptosporidium-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2588-2023
Cite this page
“BioFire FILMARRAY GI Panel Software Recall: False Cryptosporidium Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58498-biofire-filmarray-gi-panel-software-recall-false-cryptosporidium-results-risk. Based on FDA recall #Z-2588-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2588-2023%22&limit=1).
Why it’s dangerous
The software versions before FLM2-SFW-0040 v2.0.3.1 may cause the test to incorrectly show Cryptosporidium infection when it's not present. This could lead to false positive results that might affect patient care decisions.
Who’s affected
Users of the FILMARRAY GI Panel with specific model numbers and software versions prior to FLM2-SFW-0040 v2.0.3.1 are affected. Laboratory staff and healthcare providers using these panels for Cryptosporidium testing are most at risk.
How to tell if you have this one
Check for model numbers RFIT-ASY-0104 or RFIT-ASY-0116 with serial numbers starting with 00815381020116 or 00815381020109. The software version must be older than FLM2-SFW-0040 v2.0.3.1 or BFS0001-5539 v2.0.200.10.
- Brand
BioFire- Category
Medical device
What to do — step by step
Update Software
Install the latest software version FLM2-SFW-0040 v2.0.3.1 or BFS0001-5539 v2.0.200.10 to fix the false positive issue.
Where it went and when
Where it was distributed
Distributed in 50 states and D.C. and Puerto Rico.
FDA distribution: “US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT,…” 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, Maine, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-2588-2023 (April 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2588-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.