—#98005

Product

UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #: A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K042291, K060256
Affected lot / code info: UniCel DxC Clinical Systems with Serial Number less than 3412 (with serial numbers less than 3412, labeled behind the lower right side instrument door) UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #:A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102 Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP, CFR, CDQ, CEM, CGN, CGZ, CHL, DCK, DFT, JFP, JGS, JHI, JIY, JJE, JLW, JMG, JXM, LCD & LCP.

Why it was recalled

The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.

Root cause (FDA determination)

Pending

Action the firm took

The recall communication was initiated with Beckman Coulter forwarding a Product Corrective Action Letter (PCA) dated November 16, 2010 to the affected customers. The recall notice explained the reason for recall and asked that customers take the following actions: (1) Customers with a service contract will have hose clamp covers installed by their Field Service Engineer during the next scheduled Preventive Maintenance (PM). A kit can be ordered through their Customer Service Representative if consignees prefer not to wait for the next Preventive Maintenance visit and (2) Customers without a service contract can obtain a kit by contacting their local Customer Service Representative. Customers were also informed that Kit (PN A68986) containing hose clamp covers and installation instructions is available at no charge from their Customer Service Representatives. One kit is required for each DxC system. The following telephone numbers were given for customers to obtain the kits: (800) 526-3821 (United States) and (800) 463-7828 (Canada). Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If any of the affected product was forwarded on to another laboratory they were asked to provide a copy of this letter to them. Questions are to be directed to Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution--United States and countries of Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, South Korea, Spain, Slovakia, Swaziland, Sweden, Switzerland, Tunisia, Turkey, Taiwan, United Arab Emirates, and the United Kingdom.

Timeline

Recall initiated: 2010-11-16
Posted by FDA: 2011-04-13
Terminated: 2012-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.