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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 141–160 of 475 recalls

Atellica IM Folate 140 Test Kit (Siemens) – Calibration Bias (2023)

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDAJan 9, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur HBeAg Test (Siemens) – Interference Risk (2022)

Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample

FDADec 22, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Cobas Infinity Central Lab (Roche) – Order Rejection Issue (2022)

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

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FDADec 12, 2022Nationwide• Roche Diagnostics Operations, Inc.

Epoc Host 2 (Siemens) – Quality Control Pressure (2022)

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

FDADec 12, 2022Nationwide• Siemens Healthcare Diagnostics Inc

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS PTH Reagent Pack (Ortho-Clinical) – Result Bias (2022)

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

FDANov 17, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

IMMULITE 2000 Allergy IgE Kit (Siemens) – False Reactivity Risk (2022)

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

FDANov 4, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Immulite Testosterone Assay (Siemens) – Positive Bias (2022)

Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

FDAOct 25, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Accelerate PhenoTest BC Kit (Accelerate) – False Positive Risk (2022)

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

FDAOct 17, 2022AR, CA, FL +28 more• Accelerate Diagnostics Inc

VITROS Chemistry Calibrator (Ortho-Clinical) – Calibration Mathematics Issue (2022)

Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

FDAOct 13, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

FDASep 19, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

FDASep 19, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

BN ProSpec System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

BN II System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

Dimension Vista HDLC Test (Siemens) – Result Accuracy Problem (2022)

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

FDAAug 24, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Dimension Magnesium Test (Siemens) – Quality Control Problem (2022)

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

FDAAug 17, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

PTS Cholesterol Strips (PTS Diagnostics) – Instructions Error (2022)

Incorrect instructions for use were packaged into the final product.

FDAAug 16, 2022Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

IMMULITE Thyroid Test (Siemens) – Negative Bias (2022)

An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid

FDAAug 11, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS XT 7600 System (Ortho-Clinical) – Electrical Current Shift (2022)

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

FDAJul 19, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.