Manufacturer
43 recalls in our database name BioFire Diagnostics, LLC as the manufacturing or recalling firm.
Of the 43 recalls from BioFire Diagnostics, LLC 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.
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.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.
BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.
BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.
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.
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.
BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.
BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.
BioFire Diagnostics is recalling BCID2 Panels due to a risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC blood culture vials.
BioFire Diagnostics is recalling Film Array BCID Panels due to an increased risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC vials.
BioFire Diagnostics is recalling the FilmArray BCID Panel due to an increased risk of false positive Proteus results when used with specific blood culture media.
BioFire Diagnostics is recalling FilmArray BCID Panels due to a risk of false positive Proteus results when used with specific blood culture media, which may lead to improper antibiotic treatment.
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.
BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.
BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.
BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) Panel kits due to a manufacturing issue that may cause elevated rates of false positive results for HSV-1.
BioFire Diagnostics is recalling FilmArray Blood Culture Identification tests due to an increased risk of false positive results for Proteus when used with specific blood culture bottles.
BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.
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
Source: Wikidata (Q30282789), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.