Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc.

Get alerts for this brand

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 381–400 of 475 recalls

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 ...

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.

1...18 192021 22...24

Page 20 of 24Next

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

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

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

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

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.

Siemens Healthcare Diagnostics, Inc.: Siemens CentraLink Data Management System, software versi...

Laceration Risk

Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task schedulers or by actions in the CentraLink user interface may also be affected. As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.

Class IIModerate

FDAAug 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The C...

Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.

Class IIModerate

FDAAug 18, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista¿ HbA1c

In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

Class IIModerate

FDAAug 14, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas IT 1000 Product Usage: Intended Use: An e...

Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured as the Generic Patient ID (999999 by default).

Class IIModerate

FDAJul 31, 2014Nationwide• Roche Diagnostics Operations, Inc.

Diagnostica Stago, Inc.: Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA ...

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Class IIILow

FDAJul 18, 2014Nationwide• Diagnostica Stago, Inc.

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension EXL Integrated Chemistry System in vitr...

The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

Class IIModerate

FDAJul 16, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.