Reported Oct 21, 2026 · Ongoing · Updated Nov 2, 2026

Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number:…

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

Lot codes and dates: 3 of 3 products
Products covered by this recall
# Barcodes Product as published
1 0081538102031400815381020321 Lot Code: UDI Nos 00815381020314 (30 Kit), 00815381020321 (6 Kit)
2 Model Nos RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
3 Lot Numbers 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
Amount recalled: 3,871

The agency filed one notice per product. You are reading one of them; the other 2 are below.

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.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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30 in total.

#	Barcodes	Product as published
1	`0081538102031400815381020321`	Lot Code: UDI Nos 00815381020314 (30 Kit), 00815381020321 (6 Kit)
2		Model Nos RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
3		Lot Numbers 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