BioFire FilmArray Pneumonia and Joint Infection Panels
BioFire Diagnostics is recalling 3 products.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
BioFire Diagnostics, LLC began a recall on August 12, 2026, for its FilmArray Pneumonia Panel plus, BioFire Joint Infection (JI) Panel, and FilmArray Pneumonia Panel due to potential contaiminated of spefic lots that could result in false positive results. The FDA added the recall to its Enforcement Report and classified it on October 13, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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
- UDI-DI
- 00815381020192
- 00815381020208
- Lot
- 0677326
- 0806426
- 0806526
- 1289126
- 1289226
- 1405526
- 1405626
- 1413026
- 1413426
- 1413526
- 1507826
- 1613326
- 1684726
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/
Product details from the notice
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
- UDI-DI
- 00815381020314
- 00815381020321
- Lot
- 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
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/
Product details from the notice
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)
- UDI-DI
- 00815381020178
- 00815381020185
- Lot
- 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
Details
- Company began the recall
- Event ID
- 99592
- Company
- BioFire Diagnostics, LLC
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
