Events

Safety Alert for Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays

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
    2018-08-29
  • Event Date Posted
    2018-08-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180829b.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 lipase, uric acid, hdl-cholesterol, enzymatic creatinine assays medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its following devices: reference: lipase osr6x30; uric acid osr6x98; hdl-cholesterol osr6x87; enzymatic creatinine osr6x204 lot number: all lots the manufacturer informed that napqi (n-acetyl p benzoquinone imine), a metabolite of paracetamol, causes negative interference with enzymatic creatinine osr6x204, hdl- cholesterol osr6x87, lipase osr6x30 and uric acid osr6x98 assays, at levels present in the serum/plasma of overdose patients. napqi in toxic concentrations may potentially lead to erroneously low results for enzymatic creatinine, hdl cholesterol, lipase and uric acid. the risk to patient safety of this event has been determined as remote for enzymatic creatinine and highly unlikely for the remaining assays. paracetamol itself does not interfere with the assays. according to the manufacturer, no action is required by the laboratory. laboratories should be aware that there is a remote probability that napqi in toxic concentrations may potentially lead to erroneously low results for lipase, uric acid, hdl-cholesterol and enzymatic creatinine. the following statement will be added to the interfering substances section of the lipase, uric acid, hdl-cholesterol and enzymatic creatinine ifus (blosr6x30, blosr6x98, blosr6x87 and blosr6x204, respectively: "n-acetyl-p-benzoquillone imine (metabolite of paracetamol) will generate erroneously low results in samples for patients that have taken toxic doses of paracetamol. " 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 29 august 2018.

Device

Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter