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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 61–80 of 475 recalls

ADVIA Chemistry UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

Moderate

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

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Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS XT ALB-TP Slides (Ortho-Clinical) – Dust Shedding (2024)

The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.

High

FDAJul 10, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Folate Reagent Pack (Ortho-Clinical) – Precipitation Issue (2024)

It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.

Low

FDAJul 3, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Diluent Pack (Ortho-Clinical) – Sample Result Bias (2024)

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

Moderate

FDAMay 21, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

RAPIDPoint 500e Blood Gas System (Siemens) – Sample Source Identification (2024)

Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

High

FDAMay 17, 2024Nationwide• Siemens Healthcare Diagnostics Inc

VITROS Chemistry Calibrator Kit (Ortho-Clinical) – Expiration Date Error (2024)

Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.

Low

FDAMay 14, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Vitamin B12 Range Verifier (Ortho-Clinical) – Result Verification (2024)

The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.

Low

FDAMay 8, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

EsophaCap (Lucid Diagnostics) – Sponge Detachment (2024)

The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.

High

FDAApr 24, 2024Nationwide• Lucid Diagnostics, Inc.

IMMULITE 2000 Anti-TG Ab (Siemens) – Result Elevation (2024)

The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

Moderate

FDAApr 23, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Iron3 (Siemens) – Test Result Inaccuracy (2024)

Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.

FDAMar 13, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS Anti HBs Calibrators (Ortho-Clinical) – Signal Reduction Risk (2024)

Potential for positively biased results due to signal reduction over shelf life.

FDAMar 1, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

LeadCare II Blood Test (Magellan) – Calibration Mislabeling (2024)

Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

FDAFeb 23, 2024Nationwide• Magellan Diagnostics, Inc.

DCA HbA1c Reagent Kit (Siemens) – Test Result Bias (2024)

The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.

FDAFeb 7, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS 3600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 5600 System (Ortho) – QC Baseline Defect (2024)

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.