Official recall record
Diamed ID-Systems
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-03-22
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.