The Recall Desk

Manufacturer

BioFire Diagnostics, Inc.

1 recall in our database name BioFire Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2014-07-02

Of the 1 recalls from BioFire Diagnostics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-1843-2014·2014-07-02

    BioFire FilmArray Blood Culture Identification Panel Recalled for False Positives

    BioFire is recalling the FilmArray Blood Culture Identification Panel due to an increased risk of false positive results when used with specific blood culture bottles.

    Product
    FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is gro
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

BioFire Diagnostics (United States)

company in Salt Lake City, United States

Country
United States
Founded
1990

Official website

Source: Wikidata (Q30282789), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.