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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc..

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Recall Summary

Total Recalls

475

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 401–420 of 475 recalls

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Chemistry Wash (RD701) is an accessory ...

Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv

Class IIModerate

FDAJul 15, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

E-Z-HD Barium Sulfate (Bracco) – Subpotent Drug Concerns (2014)

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Class IIILow

FDAJul 2, 2014Nationwide• Bracco Diagnostic Inc

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VoLumen Barium Suspension (Bracco) – Preservative Issue (2013)

Failed Stability Testing: This product is below specification for preservative content.

Class IIILow

FDADec 16, 2013Nationwide• Bracco Diagnostics Inc

Tagitol V Barium Sulfate (Bracco) – Failed Stability Test (2013)

Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Class IIILow

FDAJul 19, 2013Nationwide• Bracco Diagnostics Inc

Gastrografin (Bracco Diagnostics) – Foreign Substance Risk (2013)

Presence of foreign substance: One lot of the product may contain black foreign particles

Class IIModerate

FDAJun 21, 2013Nationwide• Bracco Diagnostics Inc

Isovue-370 Injection (Bracco) – particulate matter (2012)

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Class IHigh

FDANov 21, 2012Nationwide• Bracco Diagnostic Inc

Isovue-300 Injection (Bracco) – particulate matter (2012)

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Class IHigh

FDANov 21, 2012Nationwide• Bracco Diagnostic Inc

Choletec Kit (Bracco) – Particulate Matter Risk (2012)

Presence of Particulate Matter; potential for charcoal particulates

Class IIILow

FDAAug 14, 2012Nationwide• Bracco Diagnostic Inc

Cardiogen-82 (Bracco Diagnostics) – Sr-82 level deviation (2012)

GMP deviation; Sr-82 levels exceeded alert limit specification

Class IIModerate

FDAJun 1, 2012Nationwide• Bracco Diagnostics Inc

Multihance Injection (Bracco) – Sterility Concern (2012)

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Class IIModerate

FDAApr 16, 2012Nationwide• Bracco Diagnostics Inc

Multihance Injection (Bracco) – Short Fill Potential (2012)

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

Class IIILow

FDAApr 16, 2012Nationwide• Bracco Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: Dimension IBCT Flex Reagent Cartridge. The total (IBCT) m...

Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.

FDADec 16, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Stratus(R) CS Rotors, catalog number CROTOR, lot number N...

Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.

FDADec 7, 2009AK, AZ, AR +25 more• Siemens Healthcare Diagnostics, Inc.

Vital Diagnostics, Inc.: ATAC Serum Control Kit. The device is used for monitorin...

Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.

FDADec 4, 2009Nationwide• Vital Diagnostics, Inc.

Vital Diagnostics, Inc.: Envoy 500 Serum Control Kit. The device is used for moni...

FDADec 4, 2009Nationwide• Vital Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista LOCI Reaction Vessel

Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.

FDANov 24, 2009CA, CO, FL +18 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics Inc: RapidPoint 400 Analyzers for Blood Gas, Electrolytes and ...

Software: Reference sensor failure may result in inaccurate pH reuslts

FDAOct 30, 2009PR• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RapidPoint 405 System Analyzers The RP405 is capable of ...

Software: Reference sensor failure may result in inaccurate pH reuslts

FDAOct 30, 2009PR• Siemens Healthcare Diagnostics Inc

Inova Diagnostics Incorporated: Inova Diagnostics BINDAZYME Human C1q binding Circulating...

The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".

FDAOct 28, 2009Nationwide• Inova Diagnostics Incorporated

Siemens Healthcare Diagnostics, Inc.: Dimension Vista CHEM 3 calibrator is an in vitro diagnos...

patient results are depressed

FDAOct 23, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.