Synchron LX and UniCel DxC Synchron Clinical Systems 의 리콜

Recall

55359

Class 2

Z-2388-2010

2010-04-15

2010-09-09

Terminated

United States

2013-12-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90668

Unicel dxc and synchron lx instruments produced inaccurate (low) glucm results. false low results could affect or delay diagnosis or treatment.

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 .