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ACCESS SYSTEM - CEA ASSAY & UNICEL IMMUNOASSAY SYSTEM -CEA ASSAYS (2015-10-12)
- Starting date:
- October 12, 2015
- 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-55654
Affected Products
A. ACCESS SYSTEM - CEA ASSAY
B. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - CEA ASSAY
C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - CEA ASSAY
Reason
Beckman Coulter has determined that the affected lots of the Access CEA Reagent packs were filled incorrectly. These packs contain insufficient quantity of reagents in one of the pack wells.
Affected products
A. ACCESS SYSTEM - CEA ASSAY
Lot or serial number
595027
595029
Model or catalog number
33200
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - CEA ASSAY
Lot or serial number
595027
595029
Model or catalog number
33200
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - CEA ASSAY
Lot or serial number
595027
595029
Model or catalog number
33200
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES