Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - ALT SLIDES (ALKALINE AMINOTRANSFERASE)

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
    55603
  • Event Risk Class
    III
  • Event Initiated Date
    2012-02-13
  • 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 received complaints of lower than expected results (<6 u/l) for samples that were known to be outside of the measuring range (>1000 u/l) when using calibration diskette/assay data diskette data release version (drv) 5653 through 5666 and vitros chemistry products alt slides (gen 26). internal investigation determined that the diskettes did not contain the appropriate supplementary calibration data for vitros alt slides (gen 26) used to flag samples greater than 1000 u/l that may have depleted the substrate. sample results that were reported between 6-1000 u/l are not affected by this issue. to correct the issue all customers that received vitros alt slides (gen 26) will be shipped drv 5667 which contains revised supplementary calibration data that will appropriately flag a sample that causes substrate depletion. following download and successful recalibration it is acceptable to resume using vitros alt slides (gen 26).

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - ALT SLIDES (ALKALINE AMINOTRANSFERASE)
  • Model / Serial
    Model Catalog: 1655281 (Lot serial: 622-0421-0410)
  • Product Description
    VITROS Chemistry Products ALT Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS