Events

Recall of Siemens RAPIDPoint® 400 and and RAPIDPoint® 405 Measurement Cartridge

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
    20623
  • Event Initiated Date
    2016-09-08
  • 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
    An error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge serial numbers 2610900214 through to 2621001325 has been identified. at extremely high chloride values (>122nmol/l) a positive bias of 5% or greater may be observed. chloride values should be interpreted in the context of all serum electrolytes (sodium, bicarbonate) and acid base status.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens RAPIDPoint® 400 and and RAPIDPoint® 405 Measurement Cartridge
  • Model / Serial
    Model: 0329756, 10341161, 10844812, 10283222, 10313971 and 10310469, Affected:
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479