Diamed ID-Systems

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. The investigations so far point out that a possible enhancer of the phenomenon is the combination of certain lots of reagents red blood cells with certain lots of associated ID-cards.

Recall start date: March 11, 2024