ACCESS IMMUNOASSAY SYSTEMS (2016-06-06)

Starting date:

June 6, 2016

Posting date:

June 30, 2016

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-59102

• Reason
• Affected products

Affected products

A. ACCESS SYSTEM - FREE T3 ASSAY

B. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY

C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY

 

Reason

Beckman Coulter has determined through customer feedback and internal testing that the affected access Free T3 Reagent lots demonstrate an upward shift in patient results. The preliminary results indicate this upward shift may be related to a June 2015 formulation design change that was introduced to improve the Access Free T3 open reagent pack stability. The upward shift in patient test results, therefore, is expected to be maintained for all future lots.

Patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the June 2015 design change. Additional assay performance characteristics are not affected. Due to matrix differences, QC values may not demonstrate a shift.

Affected products