Events

Recall of LYPHOCHEK UNASS.C.C.SERUM (HUMAN) LEVEL I (NORMAL)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD LABORATORIES ECS DIVISION.

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
    27244
  • Event Risk Class
    II
  • 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
    The reconstituted stability claims for alkaline phosphatase and tobramycin is inaccurate.

Device

LYPHOCHEK UNASS.C.C.SERUM (HUMAN) LEVEL I (NORMAL)
  • Model / Serial
    Model Catalog: (Lot serial: lot no. 15110); Model Catalog: (Lot serial: c-325-10 et 732 level 2); Model Catalog: (Lot serial: c-320-10 et 731 level 1)
  • Product Description
    lyphochek unss. cc level 1 and 2
  • Manufacturer
    BIO-RAD LABORATORIES ECS DIVISION

Manufacturer

BIO-RAD LABORATORIES ECS DIVISION
  • Manufacturer Address
    ANAHEIM
  • Source
    HC