Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
FDA Recall Z-0913-2013 · Posted 2013-03-06
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-11-28
Date Terminated2014-02-24
Product Quantity28 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.
Firm 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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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