Events

Recall of VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CK-MB REAGENT PACK

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
    27696
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-04
  • 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 revised the storage instructions for vitros immunodiagnostic products ckmb calibrators. internal testing demonstrated that opened reconstituted vitros ckmb calibrators stored at -20 c generated invalid calibrations that were detected by positively biased quality control results. as a result you must discontinue storage of opened-reconstituted vials of vitros ckmb calibrators frozen at -20 c. refrigerated storage at 2-8 c remains acceptable. the revised ifu will be posted online shortly. in the meantime the customer communication asks that customers post this communication by each vitros system that utilized vitros ckmb calibrators or with their user documentation records.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CK-MB REAGENT PACK
  • Model / Serial
    Model Catalog: 1286293 (Lot serial: All LOTS)
  • Product Description
    VITROS Immunodiagnostic Products CKMB Calibrator
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS