This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
BioArray Solution's RHD BeadChip Kit (2016-02-11)
- Starting date:
- February 11, 2016
- Posting date:
- March 4, 2016
- 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-57420
Affected Products
BioArray Solution's RHD BeadChip Kit
Reason
BioArray Solutions Ltd. Has determined that RHD master lot 16-166 has incorrect error cutoff values. Lot-specific error cutoff values for the RHD SNP markers released into the basis global software for RHD master lot 16-166 can create indeterminate genotype calls ("XX") which may impact the accuracy of the variant allele calls.
Affected products
BioArray Solution's RHD BeadChip Kit
Lot or serial number
16-166
Model or catalog number
800-10220-48
Companies
- Manufacturer
-
BIOARRAY SOLUTIONS LTD
35 TECHNOLOGY DRIVE, SUITE 100,
Warren
07059
New Jersey
UNITED STATES