Events

Recall of UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE 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
    62301
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-25
  • 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 has determined that specific access ostase calibrator and qc lots do not meet their expiration date claims within our 10% criteria. for these lots we determined that ref b83876 and b83877 have 68 days of stability and ref 37305 and 37309 have 51 days of stability. access ostase calibrator and qc instability could result in falsely elevated patient results or qc failures. for 37305/37309 the instability could cause patient results to be overestimated by as much as 16% at the original expiration dates. for b83876/b83877 the instability could cause patient results to be overestimated by as much as 16% as of october 17 2016.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY
  • Model / Serial
    Model Catalog: 37309 (Lot serial: 628296); Model Catalog: 37309 (Lot serial: 628297); Model Catalog: 37305 (Lot serial: 628297); Model Catalog: 37305 (Lot serial: 628294); Model Catalog: 37305 (Lot serial: 628296); Model Catalog: 37309 (Lot serial: 628294); Model Catalog: B83877 (Lot serial: 626001); Model Catalog: B83877 (Lot serial: 623208); Model Catalog: B83876 (Lot serial: 623207); Model Catalog: B83876 (Lot serial: 626000)
  • Product Description
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY;ACCESS SYSTEM - OSTASE ASSAY;UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY;ACCESS OSTASE QC;ACCESS OSTASE CALIBRATORS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.