Immulite 2000 System - SHBG

Starting date:

January 31, 2017

Posting date:

February 14, 2017

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-62204

• Reason
• Affected products

Reason

Certain lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8 degree Celsius, as published in the instructions for use (IFU). After a two week (14 days) period a bias in patient samples may show result in quality control falling outside of established ranges. Identified lots can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 for sex hormone-binding globulin (SHBG) concentration of 5nmol/L to 170nmol/L during the open vial adjustor stability period of 30 days. The bias observed was not concentration dependent.

Affected products