Z-1064-2009

CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated...

Name: Z-1064-2009 CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated...
Creator: Abbott Laboratories
Published: 2008-11-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-11-17 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of 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... on 2008-11-17. The reason FDA records is "Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1064-2009
Status: Terminated
Initiated: 2008-11-17
Posted: 2009-04-10
Terminated: 2010-11-27
Recalling firm: Abbott Medical
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.
Product code: GKZ Counter, Differential Cell
Reason for recall: Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 899 units
Distribution: Worldwide Distribution
Product codes and lots: Serial No. 34001BG - 34965BG

Product code GKZ

K061667Class IICell-Dyn Ruby SystemAbbott Laboratories / cleared 2006-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)