Events

Recall of SYSMEX BLOOD COAGULATION ANALYZER CS-2100I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26486
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has confirmed a carry-over risk on sysmex cs systems due to the following applications using ca-clean i (964-0631-3) for sample probe rinse: - protein c with protein c reagent (oqyg11) - protein s with ac reagent (opap03) - factor v leiden with proc global reagent (oqls13) under certain circumstances the carry-over might impact results for factor v with innovin factor xii with dade actin fsl berichrom f xiii innovance d-dimer assays. in case of innovance d-dimer only frozen samples are concerned by a potential carry-over. no impact by carry-over was observed with innovance d-dimer when using fresh normal plasma or control plasma.

Device

SYSMEX BLOOD COAGULATION ANALYZER CS-2100I
  • Model / Serial
    Model Catalog: 10488586 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CS-2100I (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 10488584 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CS-2000I (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CS-5100 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    SYSMEX BLOOD COAGULATION ANALYZER CS-2100i
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC