Events

Recall of ACCESS IMMUNOASSAY SYS - PAPP-A (PREGNANCY ASSOCIATED PLASMA PROTEIN) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    45716
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-13
  • 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
    Beckman coulter inc. identified the following issue with the above listed product: 1.Access papp-a may exhibit increased imprecision for samples tested from the first two replicates of a reagent pack as compared to the remaining replicates. 2.This issue is only observed on the access platform including access 2 synchron lxi 725 and unicel dxc 600i. 3.Unicel dxi platforms are not impacted including unicel dxi 600 unicel dxi 800 unicel dxc 880i unicel dxc 860i unicel dxc 680i and unicel dxc 660i.

Device

ACCESS IMMUNOASSAY SYS - PAPP-A (PREGNANCY ASSOCIATED PLASMA PROTEIN) ASSAY
  • Model / Serial
    Model Catalog: A48571 (Lot serial: 014411); Model Catalog: A48571 (Lot serial: 015795); Model Catalog: A48571 (Lot serial: 017948); Model Catalog: A48571 (Lot serial: 830320); Model Catalog: A48571 (Lot serial: 914085); Model Catalog: A48571 (Lot serial: 919454); Model Catalog: A48571 (Lot serial: 013968)
  • Product Description
    ACCESS IMMUNOASSAY SYS - PAPP-A (PREGNANCY ASSOCIATED PLASMA PROTEIN) ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.