Events

Recall of SYNCHRON SYSTEMS LACTATE REAGENT

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
    26572
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-18
  • 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 received customer reports of suppressed (i.E. no numerical values are produced) lact results for samples containing lact concentrations of 6.5 mmol/l or greater when using lot number m206209. beckman coulter has confirmed the issue for samples containing lact concentrations of 9.2 - 11.0 mmol/l. although these results are within the analytical range of 0.3 - 11.0 mmol/l (2.7 - 98.2 mg/dl) the results are suppressed and the system identifies the error condition rxn rate hi. numerical lact results produced without the rxn rate hi error conditions are accurate.

Device

SYNCHRON SYSTEMS LACTATE REAGENT
  • Model / Serial
    Model Catalog: A95550 (Lot serial: M206209)
  • Product Description
    SYNCHRON LX SYSTEM(S) AND UNICEL DXC 600/800 SYSTEM(S) LACTATE REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.