Device Recall BioRad brand Meridian ANA Screen ELISA Test Kit 의 리콜

Recall

56386

Class 2

Z-0613-2011

2010-02-24

2010-12-13

Terminated

United States

2011-01-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93348

False positive test results caused by decrease in the od values of ana cutoff controls and ana positive controls. the increased positivity rates were associated with the meridian ana screening kit. false positive ana values could result in misdiagnosis or mistreatment .

Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form. Bio-Rad can be contacted at 510 724-7000 concerning this recall.