Recall Z-0985-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
| Date | Feb 16, 2014 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results. |
| Root cause | Nonconforming Material/Component |
| Action | Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information. |
| Quantity | 1 unit |
| Distribution | Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |