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Health product recall

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