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Bicarbonate Reagents for Beckman Coulter AU analyzers (2015-02-17)
- Starting date:
- February 17, 2015
- Posting date:
- May 21, 2015
- 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-53397
Recalled Products
- AU2700 System - Bicarbonate Reagent
- AU5400 System - Bicarbonate Reagent
- AU System - Bicarbonate Reagent
Reason
Beckman Coulter has received a number of complaints concerning failed calibrations for specific lots of AU Bicarbonate Reagent used on Beckman Coulter AU analyzers. If calibration failures are generated using the specified lots of bicarbonate reagent, this may cause a delay in generation and release of patient results. No erroneous results will be generated as a result of this failure.
Affected products
A. AU2700 System - Bicarbonate Reagent
Lot or serial number
- 5849
- 5862
- 5871
- 5934
- 5935
- 5936
- 6074
- 6075
- 6079
Model or catalog number
- OSR6137
- OSR6237
- OSR6537
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. AU5400 System - Bicarbonate Reagent
Lot or serial number
- 5849
- 5862
- 5871
- 5934
- 5935
- 5936
- 6074
- 6075
- 6079
Model or catalog number
- OSR6137
- OSR6237
- OSR6537
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. AU System - Bicarbonate Reagent
Lot or serial number
- 5849
- 5862
- 5871
- 5934
- 5935
- 5936
- 6074
- 6075
- 6079
Model or catalog number
- OSR6137
- OSR6237
- OSR6537
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES