RHD BeadChip (2018-10-14)
- Starting date:
- October 14, 2018
- Posting date:
- November 15, 2018
- 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-68212
Affected products
RHD BeadChip
Reason
As a result of complaint investigations, Immucor has identified customers may experience an increased occurrence of LS calls and IPC failures due to lower intensities observed for RUO RHD BeadChip Kit Master Lot 18-329-U and CE RHD BeadChip Kit Master Lot 18-329-C which can lead to an incorrect phenotype assignment.
Affected products
RHD BeadChip
Lot or serial number
- ML 18-329-C
- ML 18-329-C1
Model or catalog number
800-10220-48
Companies
- Manufacturer
-
BIOARRAY SOLUTIONS LTD
35 TECHNOLOGY DRIVE, SUITE 100,
Warren
07059
New Jersey
UNITED STATES