Events

Safety Alert for Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)

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

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
    2017-07-11
  • Event Date Posted
    2017-07-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170711b.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: horiba abx sas yumizen h500 ct (closed tube) (version 2.1.0 or lower) the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning yumizen h500 ct (closed tube) (version 2.1.0 or lower), manufactured by horiba abx sas. product development activities by the manufacturer have shown that a defective positioning of the sampling needle could, in some instances, lead to a wear of the rinsing header ring of the needle. this technical issue could generate an over estimation of platelet counting. this background is usually detected when a blank cycle is performed at instrument start up (failed start up alarm). however, in other cases, the blank cycle does not detect the potential abnormal platelet background and could generate erroneous value of platelet counting. the potential overestimation of the platelet counting value could be critical for patients with thrombocytopenia and notably with severe thrombocytopenia which could then not be detected as severe. a corrective action has been identified by the manufacturer which consists of: new sampling needle adjustment needle ring replacement the manufacturer’s technician will implement the corrective action on affected yumizen h500 ct analyzer. while waiting for the corrective action, the manufacturer recommends the following solution for the patient samples with low platelet value suspicion: perform a blank cycle if blank cycle failed, re-run blank cycle if blank cycle passed, re-run their patient sample compare the 2 sample run values and repeat the procedure in case of significant discrepancy. for details, please refer to the mhra’s website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-3-to-7-july-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2017.

Device

Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HORIBA ABX SAS Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)
  • Manufacturer
    HORIBA ABX SAS

Manufacturer

HORIBA ABX SAS