Recall Z-1398-2009
Abbott Laboratories · initiated February 12, 2009
Product
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes
Codes / lots: Serial Numbers: 34868BG 34047BG 34116BG 34756BG 34012BG 34286BG 34595BG 34596BG 34597BG 34741BG 34920BG 34921BG 34922BG 34150BG 34429BG 34479BG 34518BG 34551BG 34552BG 34846BG 34526BG 34872BG 34873BG 34122BG 34657BG 34087BG 34163BG 34300BG 34537BG 34689BG 34691BG 34692BG 34283BG 34735BG 34111BG 34346BG 34416BG 34767BG 34963BG 34964BG 34965BG 34966BG 34969BG 34973BG 34974BG 34975BG 34976BG 34979BG 34001BG 34003BG 34004BG 34005BG 34010BG 34082BG 34091BG 34098BG 34110BG 34132BG 34191BG 34199BG 34227BG 34229BG 34231BG 34243BG 34324BG 34333BG 34336BG 34337BG 34434BG 34462BG 34503BG 34504BG 34507BG 34535BG 34568BG 34713BG 34733BG 34742BG 34760BG 34761BG RD009 34282BG 34021BG 34138BG 34140BG 34171BG 34384BG 34490BG 34506BG 34529BG 34668BG 34670BG 34736BG 34739BG 34870BG 34887BG 34893BG 34862BG 34863BG 34864BG 34880BG 34886BG 34860BG 34916BG 34917BG 34563BG 34565BG 34698BG 34080BG 34175BG 34247BG 34453BG 34188BG 34832BG 34833BG 34079BG 34123BG 34125BG 34448BG 34942BG 34737BG 34861BG 34907BG 34865BG 34866BG 34867BG 24525BG 34242BG 34261BG 34262BG 34263BG 34265BG 34267BG 34348BG 34353BG 34413BG 34415BG 34722BG 34101BG 34948BG 34310BG 34850BG 34851BG 34852BG 34853BG 34854BG 34855BG 34856BG…
Reason for recall
Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, burns may occur.
FDA-determined cause: Device Design
Action taken
A "Product Correction" letter dated February 12, 2009 and "Customer Reply" form were sent to all currently active CELL-DYN Ruby customers using Software Version 2.0 ML. The letter described the affected product, necessary actions and contact information for customers. Customers were instructed to acknowledge receipt of the "Product Correction" letter by completing the enclosed Customer Reply form and return via fax to 1-800-777-0051. A product information letter is being added to the accessory kits shipped with new instruments and version 2.0 ML System Software upgrade kits. For questions regarding this information, contact Abbott Laboratories Customer Support by calling 1-877-422-2688. Customers outside the US, please contact your local hematology customer support representative.
Details
- Recall number
- Z-1398-2009
- Initiated
- February 12, 2009
- Posted by FDA
- May 22, 2009
- Terminated
- December 27, 2010
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 324 units distributed
- Distribution
- Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA