medical MODERATE Updated 2026-10-21

BioFire Diagnostics, LLC recalls Generic Name: FilmArray¿ Pneumonia Panel Generic Name: Film

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Recalled Product

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) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A

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Hazard / Issue

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack); Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit); 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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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