UniCel DxI 600, 800 Access Immunoassay System - Thyroglobulin Antibody II (2019-02-09)
- Starting date:
- February 9, 2019
- Posting date:
- March 8, 2019
- 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-69230
Affected Products
- UniCel DxI 800 Access Immunoassay System - Thyroglobulin Antibody II
- Access System - Thyroglobulin Antibody II
- UniCel DxI 600 Access Immunoassay System - Thyroglobulin Antibody II
Reason
Beckman Coulter has determined through customer feedback and an internal investigation that the four affected access thyroglobulin antibody II (TgAbII) reagent lots may generate falsely decreased results in some patient samples when compared to previously released reagent lots.
The affected lots of TgAbII reagent have been shown to generate repeatable (falsely decreased) results by up to 95% in some patient samples.
Affected products
A. UniCel DxI 800 Access Immunoassay System - Thyroglobulin Antibody II
Lot or serial number
- 831710
- 831759
- 832055
- 832163
Model or catalog number
A32898
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
B. Access System - Thyroglobulin Antibody II
Lot or serial number
- 831710
- 831759
- 832055
- 832163
Model or catalog number
A32898
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
C. UniCel DxI 600 Access Immunoassay System - Thyroglobulin Antibody II
Lot or serial number
- 831710
- 831759
- 832055
- 832163
Model or catalog number
A32898
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES