Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to cal

FDA device recall Z-0613-2013 · posted 2012-12-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.

Action taken

A recall communication was initiated on July 27, 2011 with Beckman forwarding a Product Corrective Action (PCA) letter with attached PCA response form to all their customers who purchased the Access Immunoassay Systems Total T4 Calibrators. The letter provides the customers with an explanation of the problems identified and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers can call for product replacement in the US, by contacting Client Services at (800) 526-3821, option 1. Customers in Canada can contact Customer service at (800) 463-7828. Customers with questions regarding this notice can contact Customer Support Center at http:www.beckmancoulter.com or call (800) 854-3633 in the US and Canada.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JIS

Quantity affected

6,634 units total (2,742 units in US)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador,

Date initiated

2011-07-27

Date posted

2012-12-22

Date terminated

2012-12-26

Location

Brea, CA

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