The Recall Desk

FDA (Devices) recall action 88117

BioFire Diagnostics, LLC recalled 2 products on 2021-07-14

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
2021-07-14
Critical
0
Units
8,021

Why these products were recalled

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-07-14

    FilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results

    BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2021-07-14

    FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.

    Product
    FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
    Category
    Distribution
    49 states