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BioFire Diagnostics, LLC

BioFire Diagnostics, LLC Recalls

All product recalls associated with BioFire Diagnostics, LLC.

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 970 recalls

BIOFIRE Gastrointestinal Panel – False Negative Results (2023)

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

FDANov 27, 2023CA, CT, FL +13 more• BioFire Diagnostics, LLC

BIOFIRE Respiratory Panel – False Negative Results (2023)

FDANov 27, 2023CA, CT, FL +13 more• BioFire Diagnostics, LLC

QMS Tacrolimus Calibrators – Improper Storage (2023)

Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.

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FDANov 21, 2023FL, IL, IN +3 more• Ortho-Clinical Diagnostics, Inc.

RAPIDPoint Cartridge (Siemens) – sodium sensor bias (2023)

RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.

FDAOct 26, 2023Nationwide• Siemens Healthcare Diagnostics Inc

VITROS ECO2 Slides (Ortho-Clinical) – cart contamination (2023)

Laceration Risk

Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased total carbon dioxide (CO2) results leading to either overdiagnosis of acidosis or missing alkalosis, both which may prompt unnecessary therapies such as IV fluids and/or bicarbonate or overdiagnosis of alkalosis which may also result in unnecessary use of IV fluids and electrolyte replacement or failure to detect acidosis and necessary treatment.

FDAOct 25, 2023Nationwide• Ortho-Clinical Diagnostics, INc.

epoc NXS Host Blood Analysis (Siemens) – software error (2023)

Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.

FDAOct 19, 2023Nationwide• Siemens Healthcare Diagnostics Inc

BIOFIRE Blood Culture Panel (BioFire) – control panel problem (2023)

Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

FilmArray TORCH (BioFire) – power switch risk (2023)

Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

BALLARD Closed Suction System (Avanos) – DEHP labeling error (2023)

Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

FDAOct 13, 2023Nationwide• Avanos Medical, Inc.

VITROS XT 7600 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Tina-quant D-Dimer Test (Roche) – Result Elevation Issue (2023)

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

FDAOct 3, 2023Nationwide• Roche Diagnostics Operations, Inc.

RapidPoint 500e System (Siemens) – Drug Interference Risk (2023)

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

FDASep 26, 2023Nationwide• Siemens Healthcare Diagnostics Inc

RapidPoint 500 System (Siemens) – Drug Interference Risk (2023)

FDASep 26, 2023Nationwide• Siemens Healthcare Diagnostics Inc

LeadCare II Test Kit (Magellan) – Plastic Cap Issue (2023)

During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).

FDASep 19, 2023Nationwide• Magellan Diagnostics, Inc.

VITROS Lipase Slides (Ortho-Clinical) – Result Bias (2023)

Laceration Risk

Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

FDASep 12, 2023CA, CO, FL +9 more• Ortho-Clinical Diagnostics, INc.

Detector H. Pylori Test (Immunostics) – incorrect expiration date (2023)

Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.

FDAAug 25, 2023CA, MO• Immunostics, Inc.

Stay Informed

BioFire Diagnostics, LLC Recalls

Recall Summary

BIOFIRE Gastrointestinal Panel – False Negative Results (2023)

BIOFIRE Respiratory Panel – False Negative Results (2023)

QMS Tacrolimus Calibrators – Improper Storage (2023)

RAPIDPoint Cartridge (Siemens) – sodium sensor bias (2023)

VITROS ECO2 Slides (Ortho-Clinical) – cart contamination (2023)

epoc NXS Host Blood Analysis (Siemens) – software error (2023)

BIOFIRE Blood Culture Panel (BioFire) – control panel problem (2023)

FilmArray TORCH (BioFire) – power switch risk (2023)

BALLARD Closed Suction System (Avanos) – DEHP labeling error (2023)

VITROS XT 7600 System (Ortho-Clinical) – Software Issues (2023)

VITROS 4600 System (Ortho-Clinical) – Software Issues (2023)

VITROS 3600 System (Ortho-Clinical) – Software Issues (2023)

VITROS 5600 System (Ortho-Clinical) – Software Issues (2023)

VITROS XT 3400 System (Ortho-Clinical) – Software Issues (2023)

Tina-quant D-Dimer Test (Roche) – Result Elevation Issue (2023)

RapidPoint 500e System (Siemens) – Drug Interference Risk (2023)

RapidPoint 500 System (Siemens) – Drug Interference Risk (2023)

LeadCare II Test Kit (Magellan) – Plastic Cap Issue (2023)

VITROS Lipase Slides (Ortho-Clinical) – Result Bias (2023)

Detector H. Pylori Test (Immunostics) – incorrect expiration date (2023)