Access System - Cortisol Assay, UniCel DxI 600 and 800 Access Immunoassay System - Cortisol Assay (2018-09-16)
- Starting date:
- September 16, 2018
- Posting date:
- October 19, 2018
- 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-67932
Affected products
- Access System - Cortisol Assay
- UniCel DxI 600 Access Immunoassay System - Cortisol Assay
- UniCel DxI 800 Access Immunoassay System - Cortisol Assay
Reason
Beckman Coulter has determined through internal investigation that cross-contamination may have occurred between wells for the affected access cortisol reagent pack lot. Patient results may be negatively impacted (falsely decreased) by up to 16% as a result of this defect.
Affected products
A. Access System - Cortisol Assay
Lot or serial number
831755
Model or catalog number
33600
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. UniCel DxI 600 Access Immunoassay System - Cortisol Assay
Lot or serial number
831755
Model or catalog number
33600
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
C. UniCel DxI 800 Access Immunoassay System - Cortisol Assay
Lot or serial number
831755
Model or catalog number
33600
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES