Product Wiki · Recalls · Health Canada — Medical Devices

ID-DIACELL I-II — recall 55823

Health Canada — Medical Devices · Canada · 2016-11-03 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55823
Date of alert
2016-11-03
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The manufacturer reports that lot 4515.61.1 containing cells with a CCD.ee phenotype could react much more weakly during antibody screening with anti-E (anti-RH3). It is suspected that the donor's red blood cells present a Big E variant (weak ew score). Weaker reactions or even false negatives could be observed during testing, which would complicate pretransfusion analyses.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/id-diacell-ii

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