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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

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 561–580 of 970 recalls

Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur (including refurbished) Professional use...

A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

Class IIModerate

FDAOct 9, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur BNP Assay for in vitro diagnostic use in th...

Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.

Class IIILow

FDAOct 6, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension HB1C Flex reagent cartridge; Dimension ...

1...27 282930 31...49

Page 29 of 49Next

Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.

Class IIModerate

FDASep 30, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Ortho-Clinical Diagnostics: VITROS Software Version 3.1 utilized on the following sys...

Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.

Class IIILow

FDASep 29, 2014CO, MI, NJ +4 more• Ortho-Clinical Diagnostics

Siemens Healthcare Diagnostics, Inc: Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075...

Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

Class IIModerate

FDASep 26, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Roche Diagnostics Operations, Inc.: ACCU-CHEK Spirit Combo insulin infusion pump sold as part...

The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.

Class IIModerate

FDASep 25, 2014Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge T...

Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.

Class IIModerate

FDASep 24, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: External power supply adaptors that accompany Clinitek St...

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: External power supply adaptors that accompany Clinitek St...

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: External power supply adaptors that accompany Clinitek St...

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics: IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog...

Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics

E-Z-Gas Effervescent Granules (Bracco) – Subpotent Drug (2014)

Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

Class IIILow

FDASep 18, 2014Nationwide• Bracco Diagnostic Inc

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitr...

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Class IIModerate

FDASep 15, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent....

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Class IIModerate

FDASep 15, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Roche Diagnostics Operations, Inc.: Omni Micro-electrode/reference electrode for cobas b221 a...

The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.

Class IIILow

FDASep 12, 2014Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ C...

Stability of the ADVIA Centaur Cleaning Solution is not assured

Class IIILow

FDASep 12, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Abbott Ireland Diagnostics Division: ARCHITECT Total T3 Reagent Kit (7K64) consists of: - ...

17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.

Class IIModerate

FDASep 11, 2014Nationwide• Abbott Ireland Diagnostics Division

Ortho-Clinical Diagnostics: VITROS 5600 Integrated System, System Product Code 680241...

Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

Class IIModerate

FDASep 8, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 4600 Chemistry System (VITROS 5,1 FS System family...

Class IIModerate

FDASep 8, 2014Nationwide• Ortho-Clinical Diagnostics

Siemens Healthcare Diagnostics, Inc.: Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL)...

Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d

Class IIModerate

FDAAug 28, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.