Events

Recall of VITROS CHEMISTRY PRODUCTS HBA1C REAGENT KIT

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
    47348
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-26
  • 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 an inability to calibrate vitros chemistry products hba1c reagent kit generation (gen) 06 when using: vitros calibrator kit 31 lot 3155 and specific assay data diskettes ortho determined that there is an incorrect value (data/calibration mathematics) on adds (drv 5873 5874 5875 and 5876) for vitros calibrator kit 31 lot 3155 used to support vitros hba1c reagent kit gen 06. the incorrect value will prevent a successful calibration of the assay.

Device

VITROS CHEMISTRY PRODUCTS HBA1C REAGENT KIT
  • Model / Serial
    Model Catalog: 684 2905 (Lot serial: 06-5033)
  • Product Description
    VITROS Chemistry Products HbA1c Reagent Kit
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS