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ID-DIACELL I-II
- Starting date:
- October 12, 2016
- Posting date:
- November 3, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60782
Affected Products
Reason
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.
Affected products
ID-DIACELL I-II
Lot or serial number
45151.61.1
Model or catalog number
003613
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND