Events

Recall of Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 500 Test Kit

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
    20108
  • Event Initiated Date
    2016-05-02
  • 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: Abbott Diagnostics, 5440 Patrick Henry Drive, Santa Clara, California 95054, UNITED STATES OF AMERICA
  • Reason
    Manufacturer has identified a potential for increased calibration failures prior to the expiraton date for p specific lots of architect stst high sensitive troponin-1 reagent., cstomers are instructed to either:, 1. once an alternate reagent lot is available the customer is being instructed to destroy remaining inventory of affected list.Or, 2. change the expiration date of impacted lots.
  • Action
    Product to be destroyed

Device

Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 500 Test Kit
  • Model / Serial
    Model: 3P25-35 and 3P25-36, Affected: Lot Nos: 62022U100 63108U100 63137U100 62255U100 and 63051U100
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479