Events

Recall of VITROS DT NH3 SLIDES (AMMONIA)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    27298
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-16
  • 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
    Ocd has determined that the data/calibration mathematics from calibration data module (cdm prom) 0168 and 0169 for vitros chemistry products dt calibrator kit lot 44 required to support vitros chemistry products nh3 dt slides generation (gen) 59 were inadvertently omitted. without this calibration information customers will be unable to calibrate or use vitros nh3 dt slides gen 59 with vitros chemistry products dt calibrator kit lot 44 when cdm prom 0168 or 0169 is installed on their vitros dt60/dt60ii chemistry system.

Device

VITROS DT NH3 SLIDES (AMMONIA)
  • Model / Serial
    Model Catalog: 1532589 (Lot serial: 105902284417); Model Catalog: 1532589 (Lot serial: 105902280237); Model Catalog: 1532589 (Lot serial: 105902254396); Model Catalog: 1532589 (Lot serial: 105902284058)
  • Product Description
    VITROS CHEMISTRY PRODUCTS NH3 DT SLIDES
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS