—#90219

Product

UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K060256
Affected lot / code info: Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760

Why it was recalled

Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634

Recalling firm

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

Distribution

Distribution pattern: Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI

Timeline

Recall initiated: 2010-02-25
Posted by FDA: 2010-09-30
Terminated: 2012-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.