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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 341–360 of 475 recalls

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.: Atellica CH Creatine Kinase (CK_L) Reagent, Product Code ...

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

FDA

1...16 171819 20...24

Page 18 of 24Next

May 3, 2019

Nationwide

• 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.

Volumex Injection (Iso-Tex) – Sterility Concerns (2019)

Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Class IIModerate

FDAApr 15, 2019TN• Iso-Tex Diagnostics, Inc

Volumex Injection (Iso-Tex) – Sterility Risk (2019)

Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Class IIModerate

FDAMar 11, 2019TN• Iso-Tex Diagnostics, Inc

E-Z-Paste Barium Cream (Bracco) – Preservative Assay (2018)

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

Class IIModerate

FDAMar 8, 2018Nationwide• Bracco Diagnostics Inc.

Alcohol Prep Pads (Simple Diagnostics) – Sterility Concern (2017)

Lack of Assurance of Sterility and cGMP Deviations

Class IIModerate

FDASep 5, 2017Nationwide• Simple Diagnostics, Inc.

E-Z-CAT Dry (Bracco Diagnostic) – viscosity specification (2015)

Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.

Class IIILow

FDAMay 27, 2015Nationwide• Bracco Diagnostic Inc

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

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 1265 System; Siemens Material Number: 10491395,...

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: RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Numbe...

Class IIModerate

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Roche Diagnostics Operations, Inc.: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes...

Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.

Class IIModerate

FDADec 18, 2014Nationwide• Roche Diagnostics Operations, 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.

Magellan Diagnostics, Inc.: Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits ...

Laceration Risk

LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

Class IHigh

FDANov 29, 2014Nationwide• Magellan Diagnostics, Inc.

Magellan Diagnostics, Inc.: Magellan Diagnostics LeadCare Ultra Blood Analyzer Par...

Laceration Risk

Class IHigh

FDANov 29, 2014Nationwide• Magellan 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.

Express Diagnostics Int'l., Inc.: DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3...

This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results.

Class IIModerate

FDANov 21, 2014CA, MN, NY +1 more• Express Diagnostics Int'l., Inc.

Roche Diagnostics Operations, Inc.: ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usag...

Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify

Class IIModerate

FDANov 20, 2014Nationwide• Roche Diagnostics Operations, Inc.