Access and Access 2 Immunoassay System

FDA device recall Z-2384-2008 · posted 2008-09-21 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.

Action taken

A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced. If you have questions, contact Customer Technical Support at 1-800-854-3633.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CGN

Quantity affected

694 Worldwide; 656 in US & 38 in Canada total for all products

Distribution

Nationwide, and in Canada

Date initiated

2008-04-03

Date posted

2008-09-21

Date terminated

2011-11-29

Location

Brea, CA

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