Events

Recall of Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the 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
    18632
  • Event Initiated Date
    2015-06-10
  • 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
    Due to information received from the field, the potential interference of sulfasalazine and sulfapyridine in the alanine amino-transferase (alt) tests was investigated. the interference through sulfasalazine and sulfapyridine was checked for all tests using nad(h) or nadp(h). this study was done with the following strongly elevated plasma concentrations which correspond to the clsi-guideline ep-7-a2:, - 754 micromol/l sulfasalazine (300 mg/l), - 1.2 mmol/l sulfapyridine (299 mg/l), the interference depends on the pharmacokinetic and the clinical status of the patient (e.G. liver and kidney function, bowel resection etc.), which makes it impossible to provide exact information about serum drug concentration and half time.
  • Action
    Instructions for use to be updated

Device

Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) re...
  • Model / Serial
    Model: Multiple catalogue numbers, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479