Device Recall Spectrolyse PAI1 의 리콜

Recall

63016

Class 2

Z-2431-2012

2012-08-28

2012-09-20

Terminated

United States

2016-07-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112279

Spectrolyse pai-1 activity assay producing lower than expected absorbance values with "0" standard. this will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.

The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at MKHAN@AMDIAG.COM.