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 ),
FDA Recall Z-2388-2010 · Posted 2010-09-09
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2010-04-15
Date Terminated2013-12-31
Product Quantity84,186 units (79,071 in US & 5,115 in Canada)
Reason for Recall
UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.
Firm 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 probe is adequately tightened, and proper sample volume and integrity are maintained.
A copy of the PCA letter will also be included in all new instrument ship kits.
Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .
Root Cause
Other
Distribution Pattern
Worldwide Distribution: USA and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K060256UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMBeckman Coulter, Inc. · 2006-02-27K042291UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc. · 2004-11-12K023049SYNCHRON LX I 725 CLINICAL SYSTEMBeckman Coulter, Inc. · 2002-10-04K011213MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEMBeckman Coulter, Inc. · 2001-05-16K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON LBeckman Instruments, Inc. · 1997-03-10
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.