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, DiaMed GmbH, has issued a medical device safety alert concerning its Reagents for antibody screening tests ID-DiaCell I-II-III, ID-DiaCell I-II-III Asia, LISS/Coombs and Coombs Anti-IgG [HKMD Number: 230501].
The manufacturer has identified that an increased level of complaints and adverse events related to weak non-specific reactions when using ID-System screening reagents in Indirect Antiglobulin Testing (IAT) for QC, donor, and patient samples.
Customers using both the manual and instrument methods reported weak positive reaction results (identified as “?”, “wR”, “+/-”, and sometimes “+” on instruments) instead of an expected clearly negative “-“ reaction in IAT.
These doubtful reactions or in some cases weak positive reactions may occur randomly among batches.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Mar 2024