Beckman Coulter AU5800 Clinical Chemistry Analyzer. An recall: Software Issue
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Why was Beckman Coulter AU5800 Clinical Chemistry Analyzer. An recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 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.
- Recall date
- March 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)