CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology ana
FDA device recall Z-1064-2009 · posted 2009-04-10 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
- Action taken
- 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
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 899 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2008-11-17
- Date posted
- 2009-04-10
- Date terminated
- 2010-11-27
- Location
- Santa Clara, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |