166 results · 46ms · Sources: EU EUDAMED, US FDA

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epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·July 7, 2025

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·June 26, 2025

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025

Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JHM·February 3, 2021

Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JQA·November 23, 2020

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JHX·March 31, 2025

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGX·March 18, 2026

ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JQA·November 23, 2020

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGJ·November 12, 2024

Atellica IM Erythropoietin (EPO) Assay (100 Test)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GGT·January 24, 2024

ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GGT·January 24, 2024

Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGS·May 13, 2021

Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens Material Number (SMN): 10381647

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MSW·December 7, 2022

IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KTY2 Siemens Material Number (SMN): 10381648

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MSW·December 7, 2022

ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021