Recall Z-2388-2010 ยท CGA Glucose Oxidase, Glucose
Beckman Coulter Inc.
GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),
| Date | Sep 9, 2010 (initiated Apr 15, 2010) |
| Status | Terminated |
| Reason | UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment. |
| Root cause | Other |
| Action | Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample pr |
| Quantity | 84,186 units (79,071 in US & 5,115 in Canada) |
| Distribution | Worldwide Distribution: USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011213 | MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM Beckman Coulter, Inc., May 16, 2001 |
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc., Oct 4, 2002 |
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc., Nov 12, 2004 |
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Beckman Coulter, Inc., Feb 27, 2006 |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc., Mar 10, 1997 |