This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Beckman Coulter Immunochemistry Systems - Creatinine Assay
- Starting date:
- December 28, 2012
- Posting date:
- January 21, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-16871
Recalled Products
- Beckman Coulter AU2700 Immunochemistry System - Creatinine Assay
- Beckman Coulter AU5400 Immunochemistry System - Creatinine Assay
- Beckman Coulter AU Immunochemistry System - Creatinine Assay
Reason
Beckman Coulter received a report from a customer in ireland that the creatinine assay generated erroneously low creatinine results for patient samples and QC samples. The most probable cause of this issue is calibration drift due to uptake of atmospheric carbon dioxide (CO2) by a small volume of residual reagent in the creatinine reagent vial.
Affected products
B. Beckman Coulter AU2700 Immunochemistry System - Creatinine Assay
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
- OSR6178, OSR6678
Companies
- Manufacturer
- Beckman Coulter Inc.
B. Beckman Coulter AU5400 Immunochemistry System - Creatinine Assay
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
- OSR6178, OSR6678
Companies
- Manufacturer
- Beckman Coulter Inc.
C. Beckman Coulter AU Immunochemistry System - Creatinine Assay
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
- OSR6178, OSR6678
Companies
- Manufacturer
- Beckman Coulter Inc.