Reported Oct 21, 2026 · Ongoing
Generic Name: FilmArray� Pneumonia Panel Generic Name: FilmArray� Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144…
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- Generic NameFilmArray�
- Pneumonia Panel Generic NameFilmArray�
- Pneumonia Panel Model/Catalog NumberRFIT-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 VersionN/A
- Product DescriptionMultiple-type respiratory pathogen nucleic acid IVD, kit
- nucleic acid technique (NAT) ComponentN/A
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 0081538102017800815381020185Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack) 2 Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit) 3 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 - Amount recalled
- 4,892
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
This product could cause temporary or reversible health problems — stop using it.
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