Events

Recall of VITROS Chemistry Products CRP Slides

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ortho-Clinical Diagnostics Inc.

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
    20813
  • Event Initiated Date
    2016-11-11
  • 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: Ortho-Clinical Diagnostics, c/o Quigg Partners, Level 7, 36 Brandon Street, Wellington 6011
  • Reason
    Investigation confirmed that samples diluted (3x recommended dilution or higher) using vitros chemistry products specialty diluent, vitros chemistry products fs diluent pack 3 or a low crp concentration sample had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result. the magnitude of bias increases as the dilution factor increases.
  • Action
    Manufacturer to issue advice regarding use

Device

VITROS Chemistry Products CRP Slides
  • Model / Serial
    Model: , Affected: Product Codes: 1926740 - 10758750000296, 8097990 - 10758750004355, GENs: 3, 11, 12, 30 through 36
  • Manufacturer
    Ortho-Clinical Diagnostics Inc

Manufacturer

Ortho-Clinical Diagnostics Inc