Events

Recall of Ortho Clinical Diagnostics Vitros Chemistry Product Na 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
    20995
  • Event Initiated Date
    2017-11-03
  • 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/o Quigg Partners, Level 7, 36 Brandon Street, Wellington 6011
  • Reason
    The manufacturer has identified the potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1 1/2 to 8 hours then placed on the analyzer. the manufacturer has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit., follow up and resolution november 2017, the manufacturer is introducing vitros electrolyte reference fluid (erf) 300 and vitros electrolyte reference fluid (erf) 800 with a revised formulation that:, 1. restores the na+ cartridge warm-up protocol to 90 minutes when taken from the refrigerator (120 minutes from the freezer) as defined in the vitros na+ slides instructions for use., 2. reformulated erf helps to reduce sources of variability (e.G., calibration variability) observed when using vitros na+ slides.
  • Action
    Manufacturer to issue advice regarding use

Device

Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides

Manufacturer

Ortho-Clinical Diagnostics Inc