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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

242

Past Year

Class I (Serious)

Most Recent

Oct 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 221–240 of 242 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.

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...

1...10 111213

Page 12 of 13Next

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.

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

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.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge cat...

Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.

FDAOct 22, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista V-LYTE Fluids: Standard A catalog number ...

Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.

FDAOct 22, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics Inc.: IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, C...

Laceration Risk

The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with this particular lot of IgG/IgM Sample Diluent. All available lots of the IMMULITE 2000/2500 Toxoplasma IgM kits (L2KTM/L5KTM) are incompatible with Diluent lot 150

FDAOct 21, 2009Nationwide• Siemens Healthcare Diagnostics Inc.

Siemens Healthcare Diagnostics Inc.: IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, C...

Laceration Risk

FDAOct 21, 2009Nationwide• Siemens Healthcare Diagnostics Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System StreamLAB Analytical Workcell. Dim...

Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.

FDASep 1, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System CHEM 1 CAL, Catalog Number KC110, ...

Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.

FDAAug 31, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: EasyLink Informatics System included with the Dimension V...

incorrect results may be transmitted to LIS

FDAJul 14, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System BUN Flex Reagent Cartridge, Catalo...

Incorrect result: patient sample BUN results reported may be higher or lower than actual level.

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

Siemens Healthcare Diagnostics Inc.: IMMULITE 2000/2500 Chemiluminescent Substrate Module For...

These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.

FDAMay 15, 2009Nationwide• Siemens Healthcare Diagnostics Inc.

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Ca...

Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

FDAOct 3, 2008Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: Siemens Stratus CS Acute Care Troponin I CalPak. In vitr...

The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that

FDAApr 28, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Flex Reagent Cartridge C-Reactive Protein Exten...

falsely elevated results in EDTA plasma samples

FDAApr 15, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Cardiac Troponin I Flex reagent cartridge (CTN...

possibility of falsely elevated results

FDAApr 8, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.