1,182 results · 48ms · Sources: EU EUDAMED, US FDA

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Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

FDA Recall
Terminated ·Siemens Healthcare Diagnostics Inc.·Product code CIZ·June 9, 2014

Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·June 15, 2010

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics Inc.·July 23, 2014

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFR·June 29, 2017

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017

Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CIG·June 29, 2017

Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·August 31, 2011

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KLI·June 29, 2017

Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·June 29, 2017

Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NRP·June 29, 2017

Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFR·June 29, 2017

Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CIT·June 29, 2017

Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017

Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CKA·June 29, 2017

Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018