Events

Recall of ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1

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

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
    92233
  • Event Risk Class
    II
  • Event Initiated Date
    2017-07-13
  • 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
    Affected batches are positive for antibodies to hiv 1 and/or hiv 2 despite a claim on the package insert that the product is manufactured from serum or plasma that is negative for antibodies to hiv 1 and 2. there is no impact on the performance of the affected batches and the anti-hiv 1/2 positive stock used to manufacture the accurun 51 products us treated with beta propiolactone and uv radiation to reduce virus activity minimizing any safety risk.

Device

ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1
  • Model / Serial
    Model Catalog: 2000-0041 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10164524); Model Catalog: A51-5001 (Lot serial: Batch 10164524); Model Catalog: A51-5005 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10231486); Model Catalog: 2000-0041 (Lot serial: Batch 10231486); Model Catalog: A51-5001 (Lot serial: Batch 10231486); Model Catalog: A51-5005 (Lot serial: Batch 10231486); Model Catalog: 2000-0040 (Lot serial: Batch 10164525); Model Catalog: 2000-0041 (Lot serial: Batch 10164525); Model Catalog: A51-5001 (Lot serial: Batch 10164525); Model Catalog: A51-5005 (Lot serial: Batch 10164525); Model Catalog: 2000-0040 (Lot serial: Batch 10231487); Model Catalog: 2000-0041 (Lot serial: Batch 10231487); Model Catalog: A51-5001 (Lot serial: Batch 10231487); Model Catalog: A51-5005 (Lot serial: Batch 10231487)
  • Product Description
    ACCURUN 51 Multi-Marker Hepatitis Positive Control;ACCURUN 51 Multi-Marker Hepatitus Positive Control
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

SOMAGEN DIAGNOSTICS INC.
  • Manufacturer Address
    EDMONTON
  • Manufacturer Parent Company (2017)
    Diploma Plc
  • Source
    HC