Access Systems Assays (2017-05-08)

Starting date:

May 8, 2017

Posting date:

June 7, 2017

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-63512

• Reason
• Affected products

Affected Products

A. 33830 Total T3 (Access System)
B. 33880 Free T4 (Access System)
C. 33860 Free T4 (Unicel Dxi 600 Access Immunoassay System)
D. 33830 Total T3 (Unicel Dxi 600 Access Immunoassay System)
E. 33860 Thyroglobulin (Unicel Dxi 600 Access Immunoassay System)
F. 387687 Gi Monitor (Unicel Dxi 600 Access Immunoassay System)
G. 33860 Thyroglobulin (Access System)
H. 387687 Gi Monitor (Access Immunoassay System)
I. 33880 Free T4 (Unicel Dxi 800 Access Immunoassay System)
J. 33830 Total T3 (Unicel Dxi 800 Access Immunoassay System)
K. 33860 Thyroglobulin (Unicel Dxi 800 Access Immunoassay System)
L. 387687 Gi Monitor (Unicel Dxi 800 Access Immunoassay System)

Reason

Beckman Coulter has determined through internal investigation and customer feedback that the affected assays are susceptible to biotin interference with patient samples containing 100 ng/ml of biotin. Specimens that contain high levels of biotin may cause: false low results for the access GI monitor and thyroglobulin assays, and may cause false high results for the access free T4 and total T3 assays.

Affected products