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

• 
  Reason
• 
  Affected products

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