Events

Recall of RAPIDLAB 1265 SYSTEM - ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    22215
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-06
  • 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
    During some internal testing at siemens it was discovered that the d50 (glucose sensor) and d51 (lactate sensor) error codes were not functioning on the rapidlab 1260 and rapidlab 1265 instruments. glucose and lactate sensors that are not completely seated with the contacts on the instrument should alert the operator with a d50 (glucose sensor) error or a d51 (lactate sensor) error.

Device

RAPIDLAB 1265 SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: (Lot serial: 14768); Model Catalog: (Lot serial: 16314); Model Catalog: (Lot serial: 14588); Model Catalog: (Lot serial: 14532)
  • Product Description
    RAPIDLAB 1265 SYSTEM - ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC