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Panoscreen I and II (2015-02-18)
- Starting date:
- February 18, 2015
- Posting date:
- March 5, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52465
Recalled Products
Panoscreen I and II
Reason
Immucor has indicated that additional testing of Cell II (Donor C5716) has determined that the Donor is LE(B) negative, instead of LE(B) positive as indicated on the master list included with the product. Therefore, Panoscreen I and II (Lot 01888) does not include a LE(B) positive red cell. This carries a risk for Anti-LE(B) to go undetected.
Affected products
Panoscreen I and II
Lot or serial number
01888
Model or catalog number
0002380
0002390
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive
P.O. Box 5625
Georgia
UNITED STATES