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:
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:
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