UniCel DxI 600 Access Immunoassay System - Intrinsic Factor AB (2019-04-13)
- Starting date:
- April 13, 2019
- Posting date:
- May 3, 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-69834
Last updated: 2019-05-03
Affected Products
A. UniCel DxI 600 Access Immunoassay System - Intrinsic Factor AB
B. Access System - Intrinsic Factor AB
C. Intrinsic Factor AB Assay
Reason
Beckman Coulter has determined for the Access Intrinsic Factor Antibody (IFab) assay that in rare cases a "negative" result interpretation, rather than "equivocal", is assigned when the result is between 1.20 and 1.2000000476 AU/mL.
Affected products
A. UniCel DxI 600 Access Immunoassay System - Intrinsic Factor AB
Lot or serial number
All lots.
Model or catalog number
387992
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Access System - Intrinsic Factor AB
Lot or serial number
All lots.
Model or catalog number
387992
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Intrinsic Factor AB Assay
Lot or serial number
All lots.
Model or catalog number
387992
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES