Health product recall

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