Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. |
|---|---|
| Recall Number | Z-0913-2013 |
| Classification | Class II |
| Code Info | All serial numbers / Multiple manufacture dates. 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 |
| Product Distributed Qty | 28 in U.S.; 4 Canada; 318 to other foreign countries. |
| 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. |
Event Detail
| Event Id | 64000 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Beckman Coulter Inc. |
| City | Brea |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-28 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
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