Events

Safety Alert for CoaguChek XS Pro

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

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
    2013-02-19
  • Event Date Posted
    2013-02-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219b.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: roche coaguchek xs pro medical device manufacturer, roche diagnostics gmbh issued a medical device safety alert concerning an issue with erroneous decoding of ean 13 barcodes used on coaguchek xs pro. roche explained that for ean 13, iso/iec 15420 is applicable. there are 10 sizes (sc0…sc9) are specified in iso/iec 15420, with a“standard size’’ sc2 = 100%. the smallest specified symbol size (class sc0, 81.8%) is 30.50 x 21.48 mm with a module width of 0.27mm. the barcodes on the wrist bands of a customer in europe were only at approximately 49% of the sc2 standard size. on the other hand, the quality of the barcodes was found to have some deficiencies as regards correctness of guard bar and other width patterns. therefore, some ean 13-coded patient ids on wrist bands were intermittently decoded erroneously. roche will further assess further possibilities to reduce the probability of occurrence for this issue by modification to the barcode security level scanner settings. users are suggested to: ensure size and quality of barcodes used follow the applicable standards for all barcode types. avoid using ean 13 barcode types for patient and operator identification as far as possible. according to the local supplier, roche diagnostics (hong kong) limited, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.

Device

CoaguChek XS Pro
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche CoaguChek XS Pro
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH