ABBOTT PRISM HIV O Plus Assay Kit (2018-05-29)

Starting date:

May 29, 2018

Posting date:

June 6, 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-66996

• 
  Reason
• 
  Affected products

Affected products

ABBOTT PRISM HIV O Plus Assay Kit

Reason

Abbott has received customer complaints for calibration failures associated with PRISM HIV O Plus assay kit (list number 3l68-68) due to the group 0 positive assay control (opc) exceeding the prism software sample to cut-off (S/CO) upper specification. When the opc exceeds the upper specification limit, the calibration report notes an assay control failure and no results are reported for the run. An investigation to determine the cause of this issue is in progress.

Affected products