Device Recall ABX Pentra 120,120R,120DX 의 리콜

Recall

35719

Class 3

Z-1334-06

2006-03-24

2006-08-03

Terminated

United States

2012-05-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46682

Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs. In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.