| | Class 2 Recall
AU5800 Clinical Chemistry Analyzer |  |
| Date Posted |
March 06, 2013 |
| Recall Number |
Z-0913-2013 |
| Product |
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. |
| Code Information |
All serial numbers and all software versions 4.05 and prior.
Part# Item#
A94907 AU5811-02
A94912 AU5821-02
A94917 AU5831-02
A94922 AU5841-02
A94908 AU5811-03
A94913 AU5821-03
A94918 AU5831-03
A94923 AU5841-03
A94909 AU5811-04
A94914 AU5821-04
A94919 AU5831-04
A94924 AU5841-04
A94910 AU5811-06
A94915 AU5821-06
A94920 AU5831-06
A94925 AU5841-06
|
Recalling Firm/
Manufacturer |
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232 |
| For Additional Information Contact |
Noreen Galvin, PhD
714-961-4234
|
Reason for
Recall |
Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
|
| Action |
Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Call Center Hotline at (800) 854-3633 for questions regarding the notice. |
| Quantity in Commerce |
28 in U.S.; 4 Canada; 318 to other foreign countries. |
| Distribution |
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam. |
| |
|
|
|
|
