Events

Recall of Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction

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
    19326
  • Event Initiated Date
    2015-11-11
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    Temozolomide may cause interference in assays using nad(h) or nadp(h). this has been confirmed in assays for gldh, ckmb and nh3, depending on the analyser used. it has been determined that the interference occurs at either very low analyte, or too high drug concentrations., these internal investigations were carried out with the therapeutic peak plasma concentration of 0.013 mg/ml temozolomide., higher drug concentrations were not systematically tested, because no literature reference for plasma concentrations > 0.013 mg/ml was found., the maximum bias for assays which showed interference at 0.013 mg/ml temozolomide is shown below:, parameter % bias, gldh + 62%, ckmb - 31%, nh3 + 36%, this interference may results in falsely high or low results.
  • Action
    Instructions for use to be updated

Device

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction
  • Model / Serial
    Model: Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, Ammonia, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479