Events

Recall of VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

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
    91139
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-14
  • 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 issued a recall due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros 5600 integrated system vitros 4600 chemistry system and vitros 51 chemistry system. mw codes may be associated with results from any of the following vitros chemistry products using multiple point (multipoint) rate measurements: alt slides alkp slides ast slides che slides ck slides ggt slides ldh slides. multipoint rate assays measure enzyme activity via multiple readings which are used to generate a kinetic curve and calculate results. the mw algorithm assesses the validity of the kinetic curve. an mw code is generated if a single point exceeds predetermined limits provided that all surrounding values are within acceptable limits.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 2413 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 6801375 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 680 2445 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 6801890 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS