—#76304

Product

Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764, K060256
Affected lot / code info: Pump Part Numbers A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers: 973100, A30260, and A59102.

Why it was recalled

The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter contacted consignees via "Urgent Product Corrective Action" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible. For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide Distribution -- United States and Canada.

Timeline

Recall initiated: 2008-10-09
Posted by FDA: 2010-03-02
Terminated: 2012-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.