Recall Z-1873-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
| Date | Aug 2, 2013 (initiated Oct 26, 2012) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve. |
| Root cause | Software design |
| Action | A recall notification letter was forwarded to all their customers on 11/1/12 who purchased the AU5800 Clinical Chemistry Analyzer. The customers were informed of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Reponse form within 10 days. Customers with questions are instructed to call (800) 854-3633 or contact their local BCI Representative. |
| Quantity | 338 units (11 units in the US) |
| Distribution | Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112412 | AU5800(R) CHEMISTRY ANALYZER Beckman Coulter, Inc., Dec 23, 2011 |