Events

Recall of SALMONELLA AGGLUTINATING SERUM O POLY A-S

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PRO-LAB 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
    95780
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-10
  • 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
    The overall performance of the antisera has deteriorated and this is more marked in some factors than others. the product was deemed not fit for purpose as it had deteriorated since being put on the market. it was still agglutinating with most salmonella cultures tested against but was slower against some of the higher somatics as it is not detecting within one minute which is stated in the instructions for use.

Device

SALMONELLA AGGLUTINATING SERUM O POLY A-S
  • Model / Serial
    Model Catalog: PL 6002 (Lot serial: 1335)
  • Product Description
    Salmonella Agglutinating Serum O poly A-S
  • Manufacturer
    PRO-LAB DIAGNOSTICS

Manufacturer

PRO-LAB DIAGNOSTICS