Events

Recall of CHIRON RIBA HCV 3.0 STRIP IMMUNOBLOT ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    63320
  • Event Risk Class
    III
  • Event Initiated Date
    2010-03-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics recently received notification from novartis diagnostics regarding the potential for an increase in false positive assay results when using the chiron riba hcv 3.0 sia (strip immunoblot assay). internal testing of known positive specimens on retain lots yielded accurate results. therefore there is no evidence that true positive results are impacted.

Device

CHIRON RIBA HCV 3.0 STRIP IMMUNOBLOT ASSAY
  • Model / Serial
    Model Catalog: 930600 (Lot serial: YA1804); Model Catalog: 930600 (Lot serial: YA1209); Model Catalog: 930600 (Lot serial: 98743); Model Catalog: 930600 (Lot serial: 98290); Model Catalog: 930600 (Lot serial: YA1758); Model Catalog: 930600 (Lot serial: YA1691)
  • Product Description
    CHIRON RIBA HCV 3.0 SIA
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS