Events

Recall of Abbott Acetaminophen Reagent

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Sekisui Diagnostics P.E.I. 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
    18518
  • Event Initiated Date
    2015-05-14
  • 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 Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Reason
    The current instructions for use reports the interference from n-acetylcysteine (nac) evaluated on a commercially available analyser. using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/l n-acetylcysteine (nac) in a 104 mcg/ml (688 umol/l) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of nac to a serum pool., based on testing performed by sekisui diagnostics on an architect csystems instrument, the concentration of nac at which acceptable acetaminophen results are obtained is 200 mg/l nac in values from a 109 mcg/ml acetaminophen sample, tested two hours after the addition of nac to a serum pool., the package insert is being updated accordingly based on these results.
  • Action
    Product to be destroyed

Device

Abbott Acetaminophen Reagent
  • Model / Serial
    Model: List Number: 2K99-20, Affected: Lots: 4579UQ04, 46121UQ07, 46561UQ08, 46207UQ09, 46953UQ12
  • Manufacturer
    Sekisui Diagnostics P.E.I. Inc

Manufacturer

Sekisui Diagnostics P.E.I. Inc