Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Reported: March 13, 2013 Initiated: November 28, 2012 #Z-0913-2013
Product Description
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.. Recalled by Beckman Coulter Inc.. Units affected: 28 in U.S.; 4 Canada; 318 to other foreign countries..
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2013. Severity: Moderate. Recall number: Z-0913-2013.
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