BioFire Pneumonia Panel Plus Recall: Risk of Delayed Test Results
BioFire Diagnostics recalls its Pneumonia Panel Plus due to potential delayed test results from manufacturing control failures. Affected units have specific lot numbers and expiration dates.
Lower-risk recall
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling its Pneumonia Panel Plus test kits because of a manufacturing issue that might cause delayed results. This could affect healthcare providers using the product for pneumonia testing. Read more at govinfonow.com/recall/54909-biofire-pneumonia-panel-plus-recall-risk-of-delayed-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/54909-biofire-pneumonia-panel-plus-recall-risk-of-delayed-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2683-2024
Cite this page
“BioFire Pneumonia Panel Plus Recall: Risk of Delayed Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54909-biofire-pneumonia-panel-plus-recall-risk-of-delayed-test-results. Based on FDA recall #Z-2683-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2683-2024%22&limit=1).
Why it’s dangerous
The test kits have a manufacturing issue that can cause control failures, leading to delayed results. This means healthcare providers might not get accurate or timely results for pneumonia testing.
Who’s affected
Healthcare providers using the BioFire Pneumonia Panel Plus test kits are likely affected. Those who have the specific lot numbers and expiration dates listed in the recall are at risk.
How to tell if you have this one
Check for the lot number 2147723 and expiration date 27-Aug-2024 on the BioFire Pneumonia Panel Plus kit. The product is identified by the UDI-DI code 00815381020314.
- Brand
BioFire Diagnostics- 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
Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2682-2024 | BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144; UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024 | 58 |
| Z-2683-2024 | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143; UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024 | 24 Kits |
What to do — step by step
Check Product Details
Look for the lot number 2147723 and expiration date 27-Aug-2024 on the BioFire Pneumonia Panel Plus kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Indiana, West Virginia.
Recall timeline
FDA published this recall 3 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-2683-2024 (June 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2683-2024 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.