Events

Recall of Elecsys Thyroid Stimulating Hormone (TSH) and Elecsys Parathyroid Hormone (PTH) (1-84) when used on the cobas e 602 module. An in vitro diagnostic medical device (IVD).

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-2017-RN-00256-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00256-1
  • 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
    An internal error resulted in assignment of the same lot number for elecsys tsh reagents & elecsys pth (1-84) reagents. the number of tests and qc recovery of elecsys tsh lot 185522 may be affected if the elecsys pth (1-84) lot 185522 was previously used on the same cobas e 602 module. the following may occur: a reduced number of determinations for elecsys tsh assay (100 instead of 200 tests/kit); low recovery of level 2 from precicontrol universal (all lots) < -3 sd; and high recovery of precicontrol thyro sensitive & precicontrol tsh above +3 sd.This issue could cause tsh results to appear above or below the normal ranges. it cannot be excluded that a delayed or incorrect diagnosis would not occur in certain high-risk patient populations where only tsh results are used e.G. in newborn screening or pre-interventional diagnostic scenarios, leading to inadequate or inappropriate treatments. no customer complaints regarding this issue have been received by roche diagnostics to date.
  • Action
    Roche is advising users to discontinue use of Elecsys TSH reagent lot 185522 on cobas e 602 modules that have previously used Elecsys PTH (1-84) reagent lot 185522. Replacement Elecsys TSH reagents will be provided. It is recommended that users discuss with their medical director whether a look-back is required for previously affected patient results. If hyperthyroidism is excluded based on TSH results only, patients whose results were generated from lot 185522 Elecsys TSH and in the range of 0.26 – 0.36 µIU/mL should be re-tested, especially if the patient’s clinical symptoms point to hyperthyroidism.

Device

Elecsys Thyroid Stimulating Hormone (TSH) and Elecsys Parathyroid Hormone (PTH) (1-84) when used ...
  • Model / Serial
    Elecsys Thyroid Stimulating Hormone (TSH) and Elecsys Parathyroid Hormone (PTH) (1-84) when used on the cobas e 602 module. An in vitro diagnostic medical device (IVD). Elecsys TSH Material Number: 11731459122Lot Number: 185522Elecsys PTH (1-84)Material Number: 05608546190Lot Number: 185522ARTG Number: 174907
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited