Events

Recall of SYSTEM DI-60 MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYSMEX CANADA INC..

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
    20618
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-31
  • 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
    Sysmex america inc. has been made aware of a software defect on versions 5.0.1 and 6.0.1 running on the sysmex di-60 that may cause the operator to misidentify a slide flagged with a barcode error. if the sysmex di-60 processes a slide with an unreadable barcode the barcode reader will take a picture of the barcode. the software will assign the slide a temporary id beginning with err in the format of erryyyymmddhhmmss (yyyy=year mm=month dd=day hh=hour mm=minute ss=second). the image of the barcode will be stored in the database and displayed in the order data screen within the software so the customer can later identify the slide and reassign it with the correct sample id for the slide. if a subsequent slide is manually loaded on the sysmex di-60 and has a barcode with a err prefix the slide will be linked with the image of the barcode from the prior slide the sysmex di-60 found unreadable. this can give the false impression the sysmex di-60 barcode reader could not read the barcode of the subsequent slide with a barcode with the err prefix. if the user is not careful there is a risk the user will assign the slide with the err prefix printed on it with an incorrect order id via the image captured from a different slide. the sp-10 will automatically auto-assign the sample id when unable to read the barcode on the tube in the format of err050000000001 and auto-increment. these slides are not automatically routed to the sysmex di-60.

Device

SYSTEM DI-60 MAIN UNIT
  • Model / Serial
    Model Catalog: CC286297 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: BC188562 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    SYSTEM DI-60 MAIN UNIT;SYSTEM DI-60 REMOTE REVIEW SOFTWARE
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    HC