UniCel DxI 600, 800 Access Immunoassay Systems (Thyroglobulin Antibody II, Free T3 Assay, Free T4 Assay, Total T3 Assay, Thyroglobulin Assay, GI Monitor (CA 19-9))(2019-04-22)
- Starting date:
- April 22, 2019
- Posting date:
- May 17, 2019
- 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-69952
Last updated: 2019-05-17
Affected Products
A. Access System - Total T3 Assay
B. Access System - Free T3 Assay
C. Access System - Free T4 Assay
D. UniCel DxI 800 Access Immunoassay System - Thyroglobulin Antibody II
E. Access System - Thyroglobulin Antibody II
F. UniCel DxI 600 Access Immunoassay System - Free T3 Assay
G. UniCel DxI 600 Access Immunoassay System - Free T4 Assay
H. UniCel DxI 600 Access Immunoassay System - Total T3 Assay
I. UniCel DxI 600 Access Immunoassay System - Thyroglobulin Assay
J. UniCel DxI 600 Access Immunoassay System - Thyroglobulin Antibody II
K. UniCel DxI 600 Access Immunoassay System - GI Monitor (CA 19-9)
L. Access System - Thyroglobulin Assay
M. Access Immunoassay System - GI Monitor (CA 19-9)
N. UniCel DxI 800 Access Immunoassay System - Free T3 Assay
O. UniCel DxI 800 Access Immunoassay System - Free T4 Assay
P. UniCel DxI 800 Access Immunoassay System - Total T3 assay
Q. UniCel DxI 800 Access Immunoassay System - Thyroglobulin Assay
R. UniCel DxI 800 Access Immunoassay System - GI Monitor (CA 19-9) Assay
Reason
Beckman Coulter has further characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated access assays following a field action from 2017 (FA-30796), which tested biotin levels up to 100 ng/mL. Only the affected six assays displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin. Additional testing of these six assays was then performed with decreasing biotin concentrations, to identify the actual concentration above which interference could be significant:
- Access Free T3: potential of falsely elevated results when biotin concentrations are greater than 10 ng/mL.
- Access Total T3: potential of falsely elevated results when biotin concentrations are greater than 1 ng/mL.
- Access Free T4: potential of falsely elevated results when biotin concentrations are greater than 10 ng/mL.
- Access GI Monitor: potential of falsely decreased results when biotin concentrations are greater than 25 ng/mL.
- Access Thyroglobulin: potential of falsely decreased results when biotin concentrations are greater than 10 ng/mL.
- Access Thyroglobulin Antibody II: potential of falsely decreased results when biotin concentrations are greater than 100 ng/mL.
Affected products
A. Access System - Total T3 Assay
Lot or serial number
All lots.
Model or catalog number
33830
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Access System - Free T3 Assay
Lot or serial number
All lots.
Model or catalog number
A13422
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Access System - Free T4 Assay
Lot or serial number
All lots.
Model or catalog number
33880
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. UniCel DxI 800 Access Immunoassay System - Thyroglobulin Antibody II
Lot or serial number
All lots.
Model or catalog number
A32898
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E. Access System - Thyroglobulin Antibody II
Lot or serial number
All lots.
Model or catalog number
A32898
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
F. UniCel DxI 600 Access Immunoassay System - Free T3 Assay
Lot or serial number
All lots.
Model or catalog number
A13422
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
G. UniCel DxI 600 Access Immunoassay System - Free T4 Assay
Lot or serial number
All lots.
Model or catalog number
33880
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
H. UniCel DxI 600 Access Immunoassay System - Total T3 Assay
Lot or serial number
All lots.
Model or catalog number
33830
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
I. UniCel DxI 600 Access Immunoassay System - Thyroglobulin Assay
Lot or serial number
All lots.
Model or catalog number
33860
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
J. UniCel DxI 600 Access Immunoassay System - Thyroglobulin Antibody II
Lot or serial number
All lots.
Model or catalog number
A32898
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
K. UniCel DxI 600 Access Immunoassay System - GI Monitor (CA 19-9)
Lot or serial number
All lots.
Model or catalog number
387687
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
L. Access System - Thyroglobulin Assay
Lot or serial number
All lots.
Model or catalog number
33860
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
M. Access Immunoassay System - GI Monitor (CA 19-9)
Lot or serial number
All lots.
Model or catalog number
387687
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
N. UniCel DxI 800 Access Immunoassay System - Free T3 Assay
Lot or serial number
All lots.
Model or catalog number
A13422
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
O. UniCel DxI 800 Access Immunoassay System - Free T4 Assay
Lot or serial number
All lots.
Model or catalog number
33880
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
P. UniCel DxI 800 Access Immunoassay System - Total T3 assay
Lot or serial number
All lots.
Model or catalog number
33830
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
Q. UniCel DxI 800 Access Immunoassay System - Thyroglobulin Assay
Lot or serial number
All lots.
Model or catalog number
33860
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
R. UniCel DxI 800 Access Immunoassay System - GI Monitor (CA 19-9) Assay
Lot or serial number
All lots.
Model or catalog number
387687
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES