Recall Z-2132-2011 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
| Date | May 6, 2011 (initiated Apr 5, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues. |
| Root cause | Equipment maintenance |
| Action | The recall communication was initiated on 04/05/2011 with Beckman Coulter forwarding a Product Correction letter with attached customer response form to the affected customers via US Postal Service. The letter informed customers of the products affected, the issue, the impact, and the actions to be taken. Customers were instructed to follow the steps provided in order to address the issues related to microbial contamination; and to complete and return the enclosed response form within 10 days so that receipt of this important information could be confirmed. In addition, the letter requested |
| Quantity | 1284 units total for all products |
| Distribution | Worldwide Distribution -- Australia, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Hong Kong, India, Ireland, Italy, Japan, Republic of Korea, Kuwait, Mexico, Netherlands, Oman, Panama, Philippines, Puerto Rico, Saudi Arabia, Singapore, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc., Oct 4, 2002 |