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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

1000

Past Year

303

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 3801–3820 of 4747 recalls

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

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

Bystolic Tablets (Forest) – Dissolution Failure (2014)

Failed Dissolution Specification; at the 6-month stability time point

1...189 190191192 193...238

Page 191 of 238Next

Class IIModerate

FDASep 26, 2014Nationwide• Forest Pharmaceuticals Inc

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.

Benzonatate Capsules (Zydus) – Capsule Mixing (2014)

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Class IIILow

FDASep 24, 2014Nationwide• Zydus Pharmaceuticals USA 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

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

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: 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

Topiramate (Zydus) – Tablet Mix-up (2014)

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Class IIModerate

FDASep 15, 2014Nationwide• Zydus Pharmaceuticals USA 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: 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

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.

MethylPREDNISolone Tablets (Qualitest) – Subpotent Medication (2014)

Subpotent; 6 month stability time point

Class IIILow

FDASep 11, 2014Nationwide• Qualitest Pharmaceuticals

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

Wildcat Trail Side by Side (Arctic Cat) – Fire Hazard (2014)

Fire/Burn Risk

This recall involves all 2014 Arctic Cat Wildcat Trail and Wildcat Trail XT side-by-side utility vehicles with Vehicle Identification Numbers (VIN) 000001 through 316232. The VIN is located on the frame tube near the driver's side front wheel. These units were sold in red, green, lime green, team arctic green and mat black. The words "Arctic Cat" and "Wildcat Trail" appear on the sides of these vehicles and on the hood.

CPSCSep 11, 2014Nationwide• Arctic Cat, Inc., of Thief River Falls, Minn.