The Recall Desk

FDA (Devices) recall action 92397

BioFire Diagnostics, LLC recalled 2 products on 2023-08-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-08-30
Critical
0
Units
—

Why these products were recalled

Due to manufacturing issue, panels may result in false negative results.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2023-08-30

    BioFire Respiratory Panel 2.1 may produce false negative results

    BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.

    Product
    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
    Category
    Distribution
    24 states
  • HighFDA (Devices)··2023-08-30

    FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives

    BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
    Category
    Distribution
    24 states