BioFire Respiratory Panel 2.1 Recall: False Negatives Risk
BioFire Diagnostics recalls Respiratory Panel 2.1 kits due to false negative results and control failures from pouch chemistry movement. Affected kits have specific UDI and lot numbers.
Lower-risk recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling its Respiratory Panel 2.1 test kits because pouch chemistry can move unintentionally, leading to false negative results and control failures. This could mean tests don't detect infections properly, potentially missing illnesses. Read more at govinfonow.com/recall/51031-biofire-respiratory-panel-2-1-recall-false-negatives-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51031-biofire-respiratory-panel-2-1-recall-false-negatives-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0602-2026
Cite this page
“BioFire Respiratory Panel 2.1 Recall: False Negatives Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51031-biofire-respiratory-panel-2-1-recall-false-negatives-risk. Based on FDA recall #Z-0602-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0602-2026%22&limit=1).
Why it’s dangerous
The pouch chemistry in the test kit can move unintentionally during use, causing the test to show false negative results (meaning infections are missed) and control failures (tests not working as expected).
Who’s affected
Healthcare providers using the BioFire Respiratory Panel 2.1 test kits with UDI 00815381020529 or lot #2649724 are affected. Lab staff and clinics using these kits are most at risk.
How to tell if you have this one
Check for the UDI code 00815381020529 or lot number 2649724 on the kit's label. The product is a 30-test kit sold under the BioFire Respiratory Panel 2.1 brand.
- Brand
BioFire- Category
Medical device
What to do — step by step
Check Kit Label
Look for the UDI code 00815381020529 or lot number 2649724 on the test kit's label.
Where it went and when
Where it was distributed
Distributed in 11 states.
FDA distribution: “US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, Georgia, Idaho, New Hampshire, New Jersey, New York, North Carolina, Oregon, Pennsylvania, South Carolina.
Recall timeline
FDA published this recall 42 days 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-0602-2026 (October 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0602-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.