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.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Instrumentation Laboratory Company (a Werfen Company) HemoslL Liquid Anti-Xa (Part Number: 0020302600 and 0020302601) [HKMD No.: 200196].
According to the MHRA, the manufacturer has internally identified that HemoslL Liquid Anti-Xa (Part Nos. 0020302600 and 0020302601) is not meeting its labeled on-board instrument stability claim for the heparin assay of 7 days at 15-25°C for the ACL TOP Family and ACL TOP Family 50 Series. According to the manufacturer, initial testing supported a 5 day on-board stability claim; however, the manufacturer received clearance for the HemoslL Liquid Anti-Xa with a reduced stability claim of 4 days at 15-25°C.
For further information, please visit https://mhra-gov.filecamp.com/s/d/VMxSF1FeWmU9liaS
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Apr 2023