Device Recall Access Immunoassay Systems Estradiol 의 리콜

Recall

55200

Class 2

Z-0448-2011

2010-03-04

2010-11-23

Terminated

United States

2012-05-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90289

The recall was initiated after beckman coulter confirmed that three lots of access estradiol reagent (ref 33540) contains an incorrect raw material which may produce incorrect patient results.

A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. The following product replacement contacts were provided: In the United States, please contact Client Services at 1-800-526-3821. In Canada, please contact Customer Service at 1-800-463-7828. Outside the United States and Canada, contact your local Beckman Coulter Representative. Questions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.