Events

Recall of Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    18533
  • Event Initiated Date
    2018-07-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    Siemens healthcare diagnostics has confirmed that a number of lots can lead to the failure of calibration on sysmex® ca-1500, ca-7000, cs-2000i, cs-2100i, and cs-5100 instruments., in case the berichrom protein c calibration curve on the above mentioned systems is indicated as being invalid due to the 0% point of the calibration by "reaction curve error", the measurement signal does not meet the instrument's check algorithm for at least a value of 0.001dod and therefore this point gets flagged., follow-up communication, the manufacturer has issued a new protocol disc version with new and enhanced assay applications for sysmex cs-2000i/cs-2100i systems. this also includes a new protocol disc version with new and enhanced assay applications for sysmex cs-2500 systems and on sysmex cs-5100 systems.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments
  • Model / Serial
    Model: Catalogue Numbers: OUVV15 & OUVV17, Affected: First affected lot: 45059 (subsequent lots with higher lot numbers might also be affected), plus 44851
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479