Recall Z-1937-2011 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.
| Date | Apr 12, 2011 (initiated Oct 5, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack. |
| Root cause | Pending |
| Action | The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration. New bottles are opaque white |
| Quantity | 7700 units total (3178 in US) |
| Distribution | Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuad |
| 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 |