Dimension Vista System (MG) 의 리콜

Recall

72399

Class 2

Z-0339-2016

2015-11-25

Terminated

United States

2016-09-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140938

Erroneous low results on a small number of reagent wells. there is the potential for under-recovery on certain wells for quality control (qc) and patient sample results. the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to -1.6 mg/dl [0.66 mmol/l]; equivalent to a maximum negative bias of -88%.

An Urgent Medical Device Recall dated September 2015 was provided to all Dimension Vista MG customers who received the affected lot to notify them of the issue, the potential risk to health, and actions to be taken by customers. 1. An Urgent Medical Device Recall was provided to all customers who received the affected lot to notify them of the following: Siemens has received customer complaints for Dimension Vista¿ MG lot 15063BA, regarding sporadic depressed serum/plasma and QC results. Discontinue use and discard their remaining inventory of the affected lot. Review the letter with their Medical Director. Siemens will replace any unused inventory of the affected lot.