—#75463

Product

CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K061667
Affected lot / code info: Serial No. 34001BG - 34965BG

Why it was recalled

Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.

Root cause (FDA determination)

Other

Action the firm took

Recall initiated on 11/17/2008. A Product Correction letter and customer reply form is sent to all currently active CELL-DYN Ruby customers. The customers are asked to keep the communication with their CELL-DYN Ruby System Operator's Manual and to note that the information listed in the table replaces the carryover specification provided in all applications of the manual. Questions from customers in the US should be directed to Customer Support at 1-877-4ABBOTT. Customers outside the US should contact their local hematology customer support representative.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2008-11-17
Posted by FDA: 2009-04-10
Terminated: 2010-11-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.