Events

Safety Alert for Synchron Enzyme Validator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Beckman Coulter.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-01-03
  • Event Date Posted
    2017-01-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180103b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: beckman coulter, synchron enzyme validator medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron enzyme validator [product code: 441350; lot number (expiration date): m612600 (31 march 2018)]. the manufacturer has identified that a supplemental product information notification is missing from the affected lot. according to the manufacturer, customers switching from enzyme validator lots m510750 or older to lot m612600 may observe differences in ifcc enzyme methods for ggt (ref 442650 and 476846) and ast- (ref 467845 and 467849). a positive bias up to 13 u/l for ggt was observed with synchron control level 1. a negative bias up to 9% for ast- was observed with synchron control level 3. shifts in ggt and ast- were observed with other levels; however the recoveries were within the control insert ranges. customers switching from enzyme validator lot m605630 to lot m612600 are not impacted. the affected users are advised to read the supplemental product information and determine if control ranges need to be reassessed. retrospective review of patient results is at the discretion of the laboratory director. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 january 2017.

Device

Synchron Enzyme Validator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter, Synchron Enzyme Validator
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter