BioFire Joint Infection Test Kits May Give False Positives
BioFire Diagnostics recalls specific joint infection test kits that may produce false positive results due to contaminated components. Affected kits include model RFIT-ASY-0138 (30 kits) and RFIT-ASY-0135 (6 kits) with certain lot numbers.
Lower-risk recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
What happened, in plain English
BioFire Diagnostics is recalling specific joint infection test kits that could give false positive results. This means doctors might incorrectly diagnose infections when none exist, leading to unnecessary treatments. Read more at govinfonow.com/recall/1764906-biofire-diagnostics-llc-recalls-generic-name-biofire-joint-infection-ji.
Source Summary by GovInfoNow · govinfonow.com/recall/1764906-biofire-diagnostics-llc-recalls-generic-name-biofire-joint-infection-ji · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0150-2027
Cite this page
“BioFire Joint Infection Test Kits May Give False Positives.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764906-biofire-diagnostics-llc-recalls-generic-name-biofire-joint-infection-ji. Based on FDA recall #Z-0150-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0150-2027%22&limit=1).
Why it’s dangerous
The test kits contain contaminated components that can cause false positive results. This means infections might be incorrectly diagnosed, leading to unnecessary treatments or procedures.
Who’s affected
Healthcare providers using the recalled test kits are most at risk. Patients who received false positive results from these kits may have been unnecessarily treated for infections.
How to tell if you have this one
Check for model numbers RFIT-ASY-0138 (30 kit) or RFIT-ASY-0135 (6 kit). Look for lot numbers 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, or 1684726.
- Brand
BioFire Diagnostics- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0148-2027 | Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A; Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack); Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit); Lot Numbers 0638726, 0676626, 0676726, 0716526, 0727826, 0767926, 0804526, 0804626, 0860926, 0882826, 0882926, 0883026, 0914626, 0914726, 0914826, 0914926, 0969126, 0969726, 0978026, 0978126, 0978226, 0978326, 0997626, 0997826, VK0997826, 0999226, 1020826, 1020926, 1105426, 1119126, 1119226, 1119326, 1119426, 1151826, 1152326, 1152426, 1179726, 1219026, 1267526, 1286226, 1286326, 1286426, 1346126, 1402726, 1402826, 1402926, 1419126, 1419226, 1437526, 1478926, 1560326, 1560426, 1560526, 1630726, 1656826, 1683726, 1702326, 1708826 | 4,892 |
| Z-0149-2027 | Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A; Lot Code: UDI Nos 00815381020314 (30 Kit), 00815381020321 (6 Kit); Model Nos RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit); Lot Numbers 0638426, 0638526, 0676426, 0676526, 0679726, 0804826, 0804926, 0805026, 0883126, 0922126, 0941426, 0941526, 0997926, 0998026, 1020626, 1020726, 1077326, 1105326, 1118926, 1119026, 1119526, 1219226, 1239726, 1286526, 1286626, 1287326, 1287426, 1346226, 1346326, 1346426, 1403026, 1403126, 1403226, 1419326, 1419426, 1437626, 1479026, 1560626, 1560726, 1611826, 1611926, 1656926, 1683826, 1859726 | 3,871 |
| Z-0150-2027 | Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A; Lot Code: UDI Nos 00815381020192 (30 Kit), 00815381020208 (6 Kit); Model Nos RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit); Lot Numbers 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, 1684726 | 1,186 |
What to do — step by step
Check Kit Model
Identify the model number on the kit label: RFIT-ASY-0138 (30 kit) or RFIT-ASY-0135 (6 kit).
Verify Lot Number
Check the lot number on the kit label: 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, or 1684726.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any safety risks from using these kits?
The kits may produce false positive results, which could lead to unnecessary treatments. However, the recall does not indicate immediate physical harm risks.
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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-0150-2027 (August 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0150-2027 to see it in context.
- Plain-language summary written by qwen3:4b on October 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.