—#72499

Product

Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System

FDA product code: CFR — Hexokinase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K060256
Affected lot / code info: Unicel DxC 600i with Peristaltic Pumps with Serial Numbers above 22349820 ; Unicel Dxl 600 Peristaltic Pumps with Serial Numbers of 22965501 and above

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide, and in Canada

Timeline

Recall initiated: 2008-04-03
Posted by FDA: 2008-09-21
Terminated: 2011-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72499. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.