Events

Safety Alert for Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents

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
    2017-04-24
  • Event Date Posted
    2017-04-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170424a.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 systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents [reference numbers: 467825 (chol), a60298 (cr-e), a15625 (hdl), a95550 (lact), 445850 (tg and tg-b), 442785 (uric), 378194 (saly); lot numbers: all]. the manufacturer has identified the drugs metamizole (dipyrone), sulfasalazine and sulfapyridine as potential sources of interference when using synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents. with the administration of these drugs, the effects to patient analytes are: metamizole (dipyrone) – may generate false low cholesterol, enzymatic creatinine, hdl cholesterol, lactate, triglycerides and uric acid results. sulfasalazine – may generate false high salicylate results. sulfapyridine – may generate false low salicylate results. information regarding interference with these drugs will be added to the chemistry information sheets (cis) for the respective products. the cis will be updated on the beckman coulter website's technical documents webpage. 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 24 april 2017.

Device

Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and S...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter