Recall Z-0913-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
| Date | Mar 6, 2013 (initiated Nov 28, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112412 | AU5800(R) CHEMISTRY ANALYZER Beckman Coulter, Inc., Dec 23, 2011 |