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