Access/DxI Immunoassay System 의 리콜

Recall

56752

Class 2

Z-0607-2011

2010-08-13

2010-12-13

Terminated

United States

2012-07-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94447

This recall was initiated because beckman coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. erroneous results will be generated as a result of missing or incorrect assay reagents. in these cases both false positive and false negative results are possible, depending upon the assay configuration.

Beckman Coulter, Inc. sent two (2) Product Corrective Action (PCA) letters (Access letter and DxI letter) with attached Customer Response form the week of August 09, 2010 to the affected customers. The letters were dated August 13, 2010, and identified the product, the problem, and the action to be taken by the customers. The letter reminded customers that it is critical that they load reagent packs according to the procedure provided in their Access or Access 2 Operators Guide, Instructions for Use, or Help system. A copy of the procedure was included with the letter. Customers were reminded that all operators should be properly trained on these important procedures and understand the impact on reported results if these procedures are not followed. Customers were instructed to share this information with their laboratory staff, and retain this notification as part of their laboratory Quality System documentation. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633, option 1 in the United States or Canada.