Abbott Laboratories 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. Recall
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According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Serial No. 34001BG - 34965BG
Products Sold
Serial No. 34001BG - 34965BG
Abbott Laboratories is recalling CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, aut due to Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026