Device Recall UniCel DxC Synchron Clinical Systems 의 리콜

Recall

35646

Class 2

Z-1440-06

2006-05-15

2006-08-26

Terminated

United States

2013-04-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46712

Incorrect reagent status-when a new cartridge of infinity lithium reagent is loaded on to the unicel dxc system, the reagent status screen will incorrectly show 'days left' as 21. the correct reagent status for a new lithium reagent cartridge is 14 days. lithium reagent used past 14 days may produce low quality control and/or patient results.

A Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail.