Events

Recall of PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)

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-00957-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00957-1
  • 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
    Roche has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module. roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary. target values for currently available pccc1 and pccc2 control lots have been adjusted – as per the tables given in the customer letter.
  • Action
    Target values for currently available PCCC1 and PCCC2 control lots have been adjusted – as per the tables given in the Customer Letter. Users are requested to use these revised values. This action has been closed-out on 04/03/2016.

Device

PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 ...
  • Model / Serial
    PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)ARTG number: 216332
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited