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 Recall Z-1064-2009 · Posted 2009-04-10
Advertisement
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2008-11-17
Date Terminated2010-11-27
Product Quantity899 units
Reason for Recall
Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement