PreciseType HEA Molecular BeadChip Test and RHD Molecular BeadChip Test (2018-10-30)
- Starting date:
- October 30, 2018
- Posting date:
- November 28, 2018
- 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-68430
Affected products
A. PreciseType HEA Molecular BeadChip Test
B. RHD Molecular BeadChip Test
Reason
As a result of a complaint investigation, we have determined that the performance of the HEA PreciseType Beadchip Kit (IVD) listed above may be impacted by sporadic, decreased activity of the Clean-up Reagent, PN 800-00191, Lot 18-319A contained within these kits. Customers may observe an increase in occurrence of IC/LS calls when using these kits. In some instances, an incorrect call may be assigned. Additionally, although there has been no observed impact to the RHD BeadChip Kit PN 800-10220-48, Lot 19-28-C, Immucor has decided to discontinue use of Clean-up Reagent, PN 800-00191, Lot 18-319A in all BeadChip products and provide replacement Clean-up reagent to customers who have BeadChip kit lots that contain this lot of Clean-up reagent.
Affected products
A. PreciseType HEA Molecular BeadChip Test
Lot or serial number
19-21-V
Model or catalog number
800-20202-08
Companies
- Manufacturer
-
BIOARRAY SOLUTIONS LTD
35 TECHNOLOGY DRIVE, SUITE 100,
Warren
07059
New Jersey
UNITED STATES
B. RHD Molecular BeadChip Test
Lot or serial number
19-28-C
Model or catalog number
800-10220-48
Companies
- Manufacturer
-
BIOARRAY SOLUTIONS LTD
35 TECHNOLOGY DRIVE, SUITE 100,
Warren
07059
New Jersey
UNITED STATES