ABX PENTRA AST CP, 의 리콜

Recall

63838

Class 2

Z-0632-2013

2012-10-10

2013-01-03

Terminated

United States

2013-09-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114864

Horiba medical is recalling the abx pentra ast cp because during the ast application validation on the pentra c200 using an audit systems linearity kit, it was determined that two higher values for ast (expected at 800 u/l and 1000 u/l) were recorded at 280 and 199 u/l without alarm.

Horiba Medical sent a Field Safety Notification and Acknowledgement Letter dated November 20, 2012, to all affected customers. The letter notified the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 calendar days via mail, email or fax. Customers with questions were instructed to contact their local representative. For questions regarding this recall call 714-273-9254.