Events

Recall of VITROS ECI IMMUNODIAGNOSTIC SYSTEM - AFP 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
    27196
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-13
  • 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
    Ortho clinical diagnostics (ortho) has initiated this recall due to the potential of an inability to obtain a valid calibration when using vitros afp reagent packs: - vitros immunodiagnostic products afp reagent pack lot 1440 - vitros immunodiagnostic products afp calibrators lot 1440 ortho confirmed that this lot exhibited an increase in reaction signal over time. initial testing indicates that the unexpected signal increase is related to a specific lot of raw material used in the manufacture of this lot. the affected lot of vitros afp reagent packs met all quality assurance specifications upon release.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM - AFP REAGENT PACK
  • Model / Serial
    Model Catalog: 192 5551 (Lot serial: 1440); Model Catalog: 1515154 (Lot serial: 1440)
  • Product Description
    VITROS Immunodiagnostic Products AFP Reagent Pack and Calibrators
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS