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 Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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
    RC-2015-RN-00463-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00463-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • 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 µmol/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
    Roche is advising laboratories of the potential drug interference. Test instructions for use are in the process of being updated. This action has been closed-out on 11/08/2016.

Device

Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) re...
  • Model / Serial
    Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction All lots affectedARTG: 174906An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited