Events

Recall of MICROSCAN MICROSTREP PLUS PANEL TYPE 2

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
    23081
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-09
  • 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 reports regarding ampicillin and penicillin false resistance with clinical isolates and out-of-range (high) quality control (qc) results on the microstrep plus 1 (mstrp+1) and microstrep plus 2 (mstrp+2) panel lots included in this recall. beckman coulter investigation has confirmed a manufacturing error leading to antimicrobic degradation and the potential for elevated or false resistant results for some antimicrobics (e.G. ampicillin and penicillin) in a portion of the panels within these lots.

Device

MICROSCAN MICROSTREP PLUS PANEL TYPE 2
  • Model / Serial
    Model Catalog: B1027-202 (Lot serial: 2016-03-23); Model Catalog: B1027-202 (Lot serial: 2016-01-30); Model Catalog: B1027-201 (Lot serial: 2016-06-12); Model Catalog: B1027-201 (Lot serial: 2016-05-15); Model Catalog: B1027-201 (Lot serial: 2016-05-01); Model Catalog: B1027-201 (Lot serial: 2016-01-27); Model Catalog: B1027-201 (Lot serial: 2016-04-02); Model Catalog: B1027-201 (Lot serial: 2016-03-26); Model Catalog: B1027-201 (Lot serial: 2016-02-27); Model Catalog: B1027-201 (Lot serial: 2016-04-14)
  • Product Description
    MICROSTREP PLUS 2
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.