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RHD BeadChip Kit (2016-07-08)
- Starting date:
- July 8, 2016
- Posting date:
- July 29, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-59600
Affected products
A. RHD BeadChip Kit
Reason
RHD master lot has incorrect deletion detection values. Lot-specific deletion detection values released into basis global software for RHD master lot 16-284 may result in an incorrect phenotypical variant call due to the genotype being erroneously detected as having an exon 5 deletion.
Affected products
A. RHD BeadChip Kit
Lot or serial number
16-284
Model or catalog number
800-10220-48
Companies
- Manufacturer
-
BIOARRAY SOLUTIONS LTD
35 TECHNOLOGY DRIVE, SUITE 100,
Warren
07059
New Jersey
UNITED STATES