Events

Recall of ID-DiaCell ABO

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Bio-Rad Laboratories 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
    21117
  • Event Initiated Date
    2017-02-28
  • 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: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Reason
    The manufacturer has become aware of unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the id-diacell l-ll-lll and id-diapanel products. in case of doubtful reactions, please re-test with a new kit. if the results remain in doubt, the manufacturer advises to send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch., follow up 24 feb 2017: there has been further development (follow up) from our manufacturer additional 3 other devices that are also affected., the manufacturer received complaints regarding indirect antiglobulin test (iat), especially when eluates and qc samples were tested, less frequently when patient samples were tested.
  • Action
    Manufacturer to issue advice regarding use

Device

ID-DiaCell ABO
  • Model / Serial
    Model: , Affected: ID-DiaCell IP-IIP-IIIP, ID-DiaScreen VP-VIP, ID-DiaPanel-P, All lots currently in date
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc