Access Immunoassay Systems Reaction Vessels 의 리콜

Recall

66521

Class 2

Z-0519-2014

2013-10-02

2013-12-16

Terminated

United States

2014-10-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122543

Beckman coulter is initiating a recall for the access immunoassay systems reaction vessels, including the acess/access 2 immunoassay systems, syncron lxi 725 clinical system, and unicel dxc 600i synchron access clinical system because beckman coulter has observed an intermittent increase in access system "wash carousel motion errors" with specific lots of access system reaction vessels (rvs). i.

Beckman Coulter sent an Urgent Product Correction (PCA) letter dated October 1, 2013, along with a customer response form to all affected customers on October 2, 2013. The customer letter informed customers of the recall with the issue, impact, action (If your Access Immunoassay System experiences Wash Carousel Motion Errors that cannot be corrected with normal troubleshooting measures as outlined in the Access 2 Reference Manual section 6.3, contact Beckman Coulter Customer Technical Support. If you do not have Access System RVs with the lot numbers listed above, or if your Access Immunoassay System is not experiencing Wash Carousel Motion Errors, no additional action is required.), resolution, and contact information, website: http://www.beckmancoulter.com. Customers in the United States and Canada with questions were instructed to call 1-800-854-3633, outside the United States and Canada, customers were instructed to contact their local Beckman Coulter representataive. For questions regarding this recall call 714-961-4941.