Events

Field Safety Notices about Siemens Dimension® Alanine Aminotranferase (ALTI) Flex® reagent cartridge, Siemens ADVIA Chemistry 1800, 2400, XPT Ammonia (AMM), Siemens ADVIA Chemistry 1800, 2400, XPT Alanine Aminotransferase (ALT), Siemens ADVIA Chemistry 1800, 2400, XPT Salicylate (SAL), Siemens Dimension® Aspartate Aminotransferase (AST) Flex® reagent cartridge, Siemens Dimension® Glucose Flex® reagent cartridge (GLUC), Siemens Syva® Emit® 2000 Tacrolimus Sample Pretreatment Reagents/Syva® Emit® 2000 Tacrolimus Calibrators/Syva® Emit® 2000 Tacrolimus Assay

According to Health Sciences Authority (HSA), this field safety notices involved a device in Singapore that was produced by Siemens Healthcare Pte Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    600:41/01-022/17/22_59
  • Date
    2017-07-28
  • Event Country
    Singapore
  • Event Source
    HSA
  • Event Source URL
    https://www.hsa.gov.sg/announcements
  • Notes / Alerts
    Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
  • Extra notes in the data
    Siemens Healthcare Diagnostics Inc

Device

Siemens Dimension® Alanine Aminotranferase (ALTI) Flex® reagent cartridge, Siemens ADVIA Chemistr...
  • Model / Serial
  • Product Description
    Siemens Dimension® Alanine Aminotranferase (ALTI) Flex® reagent cartridge, Siemens ADVIA Chemistry 1800, 2400, XPT Ammonia (AMM), Siemens ADVIA Chemistry 1800, 2400, XPT Alanine Aminotransferase (ALT), Siemens ADVIA Chemistry 1800, 2400, XPT Salicylate (SAL), Siemens Dimension® Aspartate Aminotransferase (AST) Flex® reagent cartridge, Siemens Dimension® Glucose Flex® reagent cartridge (GLUC), Siemens Syva® Emit® 2000 Tacrolimus Sample Pretreatment Reagents/Syva® Emit® 2000 Tacrolimus Calibrators/Syva® Emit® 2000 Tacrolimus Assay, Siemens Healthcare Diagnostics Inc
  • Manufacturer
    Siemens Healthcare Pte Ltd

Manufacturer

Siemens Healthcare Pte Ltd
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HSAHSA