ABX Pentra ML 의 리콜

Recall

63829

Class 2

Z-0645-2013

2012-09-20

2013-01-07

Terminated

United States

2013-03-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114847

Horiba medical is recalling abx pentra ml because they have confirmed an issue with the abx pentra ml data management and validation system. an incorrect patient result is transmitted to the laboratory information system. this result is from a previous run of the same patient that is stored in the ml database. this issue occurs in a very rare sequence of specific events. the affected software.

.A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.