UNICEL Immunoassay System, Ostate Assay, Calibrators and QC (2016-10-25)

Starting date:

October 25, 2016

Posting date:

November 9, 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-60952

• 
  Reason
• 
  Affected products

Affected Products

A. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY

B. ACCESS SYSTEM - OSTASE ASSAY

C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY

D. ACCESS OSTASE CALIBRATORS

E. ACCESS OSTASE QC

Reason

Beckman Coulter has determined that specific Access Ostase Calibrator and QC lots do not meet their expiration date claims within our 10% criteria. For these lots we determined that REF B83876 and B83877 have 68 days of stability and REF 37305 and 37309 have 51 days of stability.

Access Ostase Calibrator and QC instability could result in falsely elevated patient results or QC failures.

For 37305/37309, the instability could cause patient results to be overestimated by as much as 16% at the original expiration dates.

For B83876/B83877, the instability could cause patient results to be overestimated by as much as 16% as of October 17, 2016.

Affected products