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 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 test due to an increase in false negative results.
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
BioFire Diagnostics is recalling its Joint Infection (JI) Panel diagnostic test kits due to contamination that may produce false positive results.
BioFire Diagnostics is recalling 23 kits of the BioFire Respiratory Panel 2.1 because unintended movement of pouch chemistry may cause false negative results and control failures.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.
BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.
BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.
BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.
BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.
The BIOFIRE BCID2 Panel may produce false positive Serratia marcescens results when used with certain culture media bottles, potentially leading to inappropriate changes in patient therapy.
BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.
BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.
BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.
BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
BioFire FilmArray TORCH diagnostic devices have a power switch that may degrade from internal arcing and carbon buildup, potentially causing electrical short, device overheating, or failure to power on.
BioFire Diagnostics is recalling FILMARRAY Gastrointestinal Panel software due to an increased risk of false positive Cryptosporidium test results. Approximately 61,069 devices were distributed in the US and internationally.
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.
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal infections.
BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.
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.