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ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ASSAYS (2015-07-27)
- Starting date:
- July 27, 2015
- Posting date:
- August 11, 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-54596
Affected Products
- UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ASSAY
- ACCESS SYSTEM - THYROGLOBULIN ASSAY
- UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ASSAY
Reason
Beckman Coulter has determined that the affected Access Thyroglobulin Reagent Pack lots may exhibit greater than 10% imprecision at concentrations
Affected products
A. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ASSAY
Lot or serial number
- 430969
- 431990
- 434727
- 522896
- 523251
Model or catalog number
- 33860
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
B. ACCESS SYSTEM - THYROGLOBULIN ASSAY
Lot or serial number
- 430969
- 431990
- 434727
- 522896
- 523251
Model or catalog number
- 33860
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ASSAY
Lot or serial number
- 430969
- 431990
- 434727
- 522896
- 523251
Model or catalog number
- 33860
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
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