Recall Z-1430-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
| Date | May 29, 2013 (initiated Apr 26, 2013) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak. |
| Root cause | Component design/selection |
| Action | Beckman Coulter sent an Urgent Product Correction letter on April 26, 2013 along with a response form. The letter notified customers of the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-854-3633 for questions regarding this notice. |
| Quantity | 108 units |
| Distribution | Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP. |
| FDA record | Open on fda.gov |