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LIFECODES LifeScreen Deluxe (LMX) (2015-10-13)
- Starting date:
- October 13, 2015
- 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-55716
Affected Products
LIFECODES LifeScreen Deluxe (LMX)
Reason
During in-house stability testing at test point 9 months, with LMX Lot 3002350, we observed false positive results with a single sample. The sample is expected to test negative for both human leukocyte antigen (HLA) class I and class II. The sample gave a qualitative result of CI (-), COO (+), indicating a false positive for HLA class II.
Affected products
LIFECODES LifeScreen Deluxe (LMX)
Lot or serial number
3002350
Model or catalog number
628215
Companies
- Manufacturer
-
Immucor Transplant Diagnostics, Inc.
550 West Avenue
Stamford
06902
Connecticut
UNITED STATES