Events

Safety Alert for Access CEA Reagent Kit for UniCel DxI Immunoassay Systems and Access 2 Immunoassay System

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

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
    2015-10-16
  • Event Date Posted
    2015-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151016a.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 access cea reagent kit for unicel dxi immunoassay systems and access 2 immunoassay system medical device manufacturer, beckman coulter incorporation, has issued a medical device safety alert concerning its cea reagent kit for unicel dxi 800, unicel dxi 600, unicel dxc 600i, unicel dxc 880i, unicel dxc 860i, unicel dxc 680i, unicel dxc 660i and access 2 immunoassay systems [reference number: 33200; lot number: 595027 (15-feb-16), 595029 (28-feb-16)]. the manufacturer has determined that the access cea reagent packs of the lots listed above were filled incorrectly. the affected packs contain insufficient quantity of reagents in one of the pack wells. according to the manufacturer, the impact is dependent upon the instrument and software version installed at the time the reagent lot was in use: access 2 systems running software version 3.3.1 or lower, and access 2i systems running software version 6.1 or lower with these reagent lots: the instrument may have generated incorrect results of 0.0 ng/ml when using an affected pack. all other results greater than 0.0 ng/ml are not affected by this issue and are correct. access 2 systems running software version 3.4.2 and access 2i systems running software version 6.2.2 or higher with these lots: the affected packs would have been detected by process monitoring with a result flag qsd (indicates reagent dispense is insufficient), and the pack would have been disabled by the instrument. no patient result would have been generated. unicel dxi systems running any software version: the packs would have been detected by reagent pack monitoring with a result flag qsd, and the pack would have been disabled by the instrument. no patient result would have been generated. all users that received the affected lots listed above are advised to discard the access cea reagent pack lots listed above. for access 2 users with software version 3.3.1 or lower and access 2i users with software version 6.1 or lower, they are advised to review their patient results that were reported as 0.0 ng/ml and did not match the clinical status of the patients. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2015.

Device

Access CEA Reagent Kit for UniCel DxI Immunoassay Systems and Access 2 Immunoassay System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Access CEA Reagent Kit for UniCel DxI Immunoassay Systems and Access 2 Immunoassay System
  • Manufacturer
    Beckman Coulter Incorporation

Manufacturer

Beckman Coulter Incorporation