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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

1000

Past Year

304

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 381–400 of 4747 recalls

FilmArray 2.0 Instrument (BioFire) - Calibration Equipment Problem (2024)

Salmonella

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

Hydrocortisone Otic Solution (Taro) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Class IIILow

FDAAug 7, 2024Nationwide• Taro Pharmaceuticals U.S.A., Inc.

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FilmArray Torch Module (BioFire) - Calibration Equipment Problem (2024)

Salmonella

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

Methotrexate Tablets (Amneal) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Class IIILow

FDAAug 1, 2024Nationwide• Amneal Pharmaceuticals, LLC

Indomethacin Capsules (Glenmark) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: below specification results

Class IIModerate

FDAJul 31, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Gabapentin Tablets (Granules) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

Class IIModerate

FDAJul 31, 2024Nationwide• Granules Pharmaceuticals Inc.

Dimension Vista TBIL Reagent (Siemens) – Testing Limitation (2024)

During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

FDAJul 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/... (Intrinsic Therapeutics, Inc.) – at least two units have been found to... (2024)

At least two units have been found to be missing a weld.

FDAJul 25, 2024Nationwide• Intrinsic Therapeutics, Inc.

Azelaic Acid Gel (Glenmark) – CGMP Deviation (2024)

CGMP Deviations

Class IIModerate

FDAJul 22, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

VITROS XT ALB-TP Slides (Ortho-Clinical) – Dust Shedding (2024)

The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.

FDAJul 10, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Clonazepam Tablets (Endo) – Labeling Error (2024)

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

Class IHigh

FDAJul 10, 2024Nationwide• Endo Pharmaceuticals, Inc.

Nitrofurantoin Capsules (Sun Pharma) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAJul 9, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Acetaminophen Injection (Hikma) – Label Mix-up (2024)

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

Class IHigh

FDAJul 8, 2024OH, PR• Hikma Pharmaceuticals USA Inc.