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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

1000

Past Year

303

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 1581–1600 of 4747 recalls

Siemens Healthcare Diagnostics Inc.: Siemens IMMULITE 2000 XPi Immunoassay System - In vitro C...

Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard

FDAMay 15, 2020Nationwide• Siemens Healthcare Diagnostics Inc.

Estriol USP (Triova) – Impurity Specification Failure (2020)

Failed impurities/ degradation specifications: Out of specification for organic impurities.

Class IIModerate

FDAMay 15, 2020Nationwide• TRIOVA PHARMACEUTICALS LLC

Doxycycline Tablets (PD-Rx) – Failed Dissolution (2020)

Failed dissolution specifications

Class II

1...78 798081 82...238

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Moderate

FDAMay 15, 2020Nationwide• PD-Rx Pharmaceuticals, Inc.

Siemens Healthcare Diagnostics, Inc.: (1) Atellica Data Manager software version 1.0 Siemens Ma...

Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review

FDAMay 15, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Wintergreen Essential Oil (Aromatics International) - Packaging Concern (2020)

This recall involves Aromatics International Wintergreen Essential Oil in 5 mL, 15 mL, 30 mL, and 100 mL glass amber bottes with a black continuous thread cap. The bottles have a white label with the firm's green logo on the front. UPC codes are listed on the 5 mL (817697021443) and 15 mL (817697021375) along the bar code. The batch numbers WIN-104 and WIN-105 are listed on a dot sticker located on the cap.

CPSCMay 14, 2020Nationwide• Aromatics International LLC, of Florence, Mont.

Gabapentin Tablets (InvaGen) – Impurity Test Failure (2020)

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

Class IIILow

FDAMay 14, 2020Nationwide• InvaGen Pharmaceuticals, Inc.

Ortho-Clinical Diagnostics: VITROS Chemistry Product Performance Verifier I, Product ...

Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.

FDAMay 11, 2020Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 P...

FDAMay 11, 2020Nationwide• Ortho-Clinical Diagnostics

Siemens Healthcare Diagnostics, Inc.: Atellica Solution IM1300 Analyzer, Siemens Material Numbe...

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.

FDAMay 7, 2020AL, AZ, CA +41 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica Solution IM1600 Analyzer, Siemens Material Numbe...

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

FDAMay 7, 2020AL, AZ, CA +41 more• Siemens Healthcare Diagnostics, Inc.