Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Thermo Fisher Scientific, has issued a medical device safety alert concerning Phadia 200 [Material number: 12-4300-00; Affected Serial Number: SN00338, SN00339, SN00340, SN00341, SN00342, SN00343, SN00344, SN00345, SN00346, SN00347, SN00348, SN00349, SN00350, SN00351, SN00352, SN00353, SN00354, SN00355, SN00356, SN00357, SN00358, SN00359, SN00360, SN00361, SN00362, SN00363, SN00364, SN00365, SN00366, SN00367, SN00368, SN00369, SN00370, SN00371, SN00372; Associated devices Spare part: Dispensing claw (12-4303-08), lot R8LW] [HKMD No.: 210044, 210045, 220204].
The manufacturer has been discovered that lot R8LW of the Dispensing Claws may break more easily due to a manufacturing issue. The lot has been installed in Phadia 200 instruments and if it were to break, the customer would experience problems with dispensing and there may be a delay in test results. There is no impact on previously reported or future test results produced on the affected instruments. According to the manufacturer, there have been no reports of adverse events due to this issue.
The manufacturer will contact the affected users to replace the dispensing claw. Affected users should follow the action listed on the customer letter issued by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 May 2023