Events

Recall of Vitros Performance verifier 1

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
    18611
  • Event Initiated Date
    2015-06-03
  • 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/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer has observed a positive bias with the first slide used from a cartridge that has been stored in the slide supply. the bias has been observed with multiple fluids across multiple gens and coating of slides and across the 5,1.Fs, 4600 amd 5600 analyzer platforms. the frist slide bias may occur when a cartridge is loaded on an analyzer and is not used for approximately 5-14 days., ocd has revised the range of means for vitros performance verifier1 for unconjugated biirubin (bu) only.
  • Action
    Manufacturer to issue advice regarding use

Device

Vitros Performance verifier 1
  • Model / Serial
    Model: 8067324, Affected: Lot Numbers: A3823 C4084 Q2961 T3161 V3297 and X3569
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479