Events

Recall of AMMONIA (NH3) ENZYMATIC UV MANUAL METHOD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RANDOX LABORATORIES LTD..

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
    77323
  • Event Risk Class
    III
  • Event Initiated Date
    2015-10-14
  • 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
    Patient samples will recover with a positive bias of approximately 60umol/l when using ammonia catalogue numbers: am1015 batch: 326173 am1054 batch: 326180 am8112 batch: 326186. this issue will not be evident in the control material being used.

Device

AMMONIA (NH3) ENZYMATIC UV MANUAL METHOD
  • Model / Serial
    Model Catalog: AM1015 (Lot serial: 326173)
  • Product Description
    AMMONIA
  • Manufacturer
    RANDOX LABORATORIES LTD.

Manufacturer

RANDOX LABORATORIES LTD.