Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518, Access 2 APF W

FDA device recall Z-1373-2012 · posted 2012-04-06 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.

Action taken

Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representative.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

2948 units total (2762 units in the US)

Distribution

Worldwide Distribution-USA (nationwide) and the country of Canada.

Date initiated

2008-09-11

Date posted

2012-04-06

Date terminated

2012-06-26

Location

Brea, CA