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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

242

Past Year

Class I (Serious)

Most Recent

Oct 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 181–200 of 242 recalls

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.1...

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

FDAAug 15, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material N...

Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure

FDAAug 14, 2019Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: Siemens Atellica CH 930 Analyzer. Siemens Material Num...

1...8 91011 12 13

Page 10 of 13Next

Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below

FDAJul 30, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur Folate 100 test kit-for IVD of fola...

Homocysteine Assay May Cause Elevated Results in the Folate Assay

FDAJul 22, 2019Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of fo...

Homocysteine Assay May Cause Elevated Results in the Folate Assay

FDAJul 22, 2019Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: Dimension Ferritin (FERR) Flex reagent cartridge DM FERR...

Negative Bias with Lot EA9227.

FDAJul 15, 2019AK, AZ, AR +32 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.

FDAJul 10, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and...

FDAJul 10, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: N Cuvette Segments for BN ProSpec System-IVD a system for...

Iincreased (falsely elevated) Albumin results compared to expected results

FDAJun 27, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics Inc: Stratus CS Acute Care cTNI TestPak, SMN 10445071 Produ...

Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

FDAMay 29, 2019Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product C...

A steady upward trend in blank (u) absorbance was observed

FDAMay 3, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Creatine Kinase (CK_L) Reagent, Product Code ...

A steady upward trend in blank (u) absorbance was observed

FDAMay 3, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics Inc: RAPIDLab 1265 System; Siemens Material Number: 10491395,...

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

Class IIModerate

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RAPIDLab 1245 System; Siemens Material Number: 10321844,...

Class IIModerate

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Numbe...

Class IIModerate

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Numbe...

Class IIModerate

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry XPT interfaced to the CentraLink Data Ma...

Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.

Class IIModerate

FDADec 16, 2014IN, WA• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD08...

Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.

Class IIModerate

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

Siemens Healthcare Diagnostics, Inc.: Dimension Vista 500 Intelligent Lab System or Dimension V...

Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

Class IIModerate

FDANov 5, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Turbo Troponin I For in vitro diagnostic use for the q...

Class IIModerate

FDAOct 27, 2014CO, FL, IN +3 more• Siemens Healthcare Diagnostics, Inc.