Health product recall

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

  1. UniCel DxI 800 Access  Immunoassay System - Thyroglobulin Antibody II
  2. Access System - Thyroglobulin Antibody II
  3. 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