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Synchron CX and LX Reagents (2014-01-29)
- Starting date:
- January 29, 2014
- Posting date:
- March 18, 2014
- 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-38329
Recalled Products
Synchron CX and LX Reagents
Reason
Beckman Coulter has identified that some of the reagent bottles listed above may have been released without immediate container labels. However, the outer container labels were appropriately applied to the outer packaging.
Affected products
A. Synchron CX3 Clinical System Analyzer - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
445865
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Synchron CX5 System Analyzer - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
445865
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Synchron CX4 System Analyzer - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
445865
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. Synchron CX7 System Analyzer - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
445865
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E. Synchron LX20 System Analyzer - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
445865
472481
A28937
A28945
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
F. Synchron CX9 ALX System Analyzer - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
445865
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
G. Synchron LX Systems Albumin (ALBM) Reagent
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
467858
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
H. Synchron LX Systems Phosphorus (PHPSM) Reagent
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
467868
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
I. Synchron LX Systems Creatinine Reagent
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
472525
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES