Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - CA SLIDES (CALCIUM)

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
    75785
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-24
  • 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 a potential for negatively biased serum sample results to be generated when using vitros ca slides gen 29. ortho confirmed an average negative bias of -0.45 mg/dl (-0.11 mmol/l) within the serum reference interval (8.4 - 10.2 mg/dl or (2.10 - 2.55 mmol/l) when using vitros ca slides gen 29. plasma and serum samples are similarly affected as both sample types use the same calibration parameters (math) when results are produced. though unconfirmed to date ortho has no indication that urine sample results generated when using vitros ca slides gen 29 are affected. as a result customers are being instructed to discontinue the use of vitros ca slides gen 29.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - CA SLIDES (CALCIUM)
  • Model / Serial
    Model Catalog: 1450261 (Lot serial: 0329-0528-9265); Model Catalog: 1450261 (Lot serial: 0329-0528-9176); Model Catalog: 1450261 (Lot serial: 0329-0528-8902); Model Catalog: 1450261 (Lot serial: 0329-0528-6999); Model Catalog: 1450261 (Lot serial: 0329-0528-9167)
  • Product Description
    VITROS Chemistry Products Calcium (Ca) Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS