BioFire Respiratory Panel 2.1 May Give False Negative Results
BioFire Diagnostics recalls Respiratory Panel 2.1 (RP2.1) with REF 423742 due to potential false negative results. Affected units have specific lot numbers and expiration dates.
Lower-risk recall
Due to manufacturing issue, panels may result in false negative results.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling Respiratory Panel 2.1 (RP2.1) with REF 423742 because manufacturing issues could cause false negative results. This means tests might incorrectly show no infection when one is present, potentially leading to missed diagnoses. Read more at govinfonow.com/recall/58452-biofire-respiratory-panel-2-1-may-give-false-negative-results.
Source Summary by GovInfoNow · govinfonow.com/recall/58452-biofire-respiratory-panel-2-1-may-give-false-negative-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2439-2023
Cite this page
“BioFire Respiratory Panel 2.1 May Give False Negative Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58452-biofire-respiratory-panel-2-1-may-give-false-negative-results. Based on FDA recall #Z-2439-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2439-2023%22&limit=1).
Why it’s dangerous
The panels may produce false negative results due to a manufacturing issue. This means the test might show a patient is not infected when they actually are, leading to missed diagnoses and potential spread of infection.
Who’s affected
Healthcare providers using the BioFire Respiratory Panel 2.1 for respiratory testing are likely affected. Patients relying on accurate test results could be at risk of undiagnosed infections.
How to tell if you have this one
Check for the product name 'BioFire Respiratory Panel 2.1 (RP2.1)' with reference number 423742. Affected units have specific pouch lot numbers (e.g., 2MRG22, 2N0Z22) and expiration dates listed in the recall notice.
- Brand
BioFire- Category
Medical device
All 2 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
US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2439-2023 | BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only; Pouch Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23, Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23, Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23, Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23, Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23, Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23, Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23, Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23, Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23, Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23, Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23, Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23, Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23, Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23, Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23, Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23, Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23, Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23, Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23, Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23, Pouch Lot # 2N6222 Kit # 2168322 Exp. 22-Nov-23, Pouch Lot # 2N6R22 Kit # 2170622 Exp. 23-Nov-23, Pouch Lot # 2N6S22 Kit # 2170722 Exp. 23-Nov-23, Pouch Lot # 2N6W22 Kit # 2171122 Exp. 21-Nov-23, Pouch Lot # 2N6X22 Kit # 2171222 Exp. 22-Nov-23, Pouch Lot # 2N7422 Kit # 2171922 Exp. 26-Nov-23, ;UDI-DI: UDI: 00815381020482 | 705 kits (30 pouches/kit) |
| Z-2440-2023 | FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only; Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482 | 24 Kits (30 pouches/kit) |
What to do — step by step
Check Product Details
Review the pouch lot number and kit number on the product to see if it matches the affected lots listed in the recall.
Where it went and when
Where it was distributed
Distributed in 24 states, and outside the U.S.
FDA distribution: “US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Utah, West Virginia.
Recall timeline
FDA published this recall 4 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-2439-2023 (May 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2439-2023 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.