CELLDYN Ruby

Affected serial numbers:  70002BG 70026BG 70050BG 70076BG 70105BG 70141BG 70003BG 70028BG 70051BG 70077BG 70106BG 70142BG 70004BG 70029BG 70052BG 70079BG 70107BG 70144BG 70005BG 70030BG 70054BG 70082BG 70113BG 70146BG 70006BG 70031BG 70056BG 70084BG 70114BG 70147BG 70007BG 70032BG 70058BG 70086BG 70119BG 70149BG 70008BG 70033BG 70059BG 70087BG 70120BG 70164BG 70009BG 70034BG 70061BG 70088BG 70124BG 70165BG 70010BG 70035BG 70063BG 70089BG 70125BG 70166BG 70011BG 70036BG 70064BG 70090BG 70127BG 70167BG 70012BG 70037BG 70065BG 70091BG 70129BG 70170BG 70013BG 70038BG 70067BG 70092BG 70130BG 70171BG 70014BG 70039BG 70068BG 70093BG 70131BG 70178BG 70016BG 70040BG 70069BG 70094BG 70132BG 70181BG 70018BG 70042BG 70070BG 70095BG 70133BG 70183BG 70019BG 70043BG 70071BG 70096BG 70134BG 70189BG 70020BG 70044BG 70072BG 70099BG 70136BG 70021BG 70045BG 70073BG 70100BG 70137BG 70024BG 70046BG 70074BG 70103BG 70138BG 70025BG 70047BG 70075BG 70104BG 70140BG.  UPDATE: 2-28-17 - five additional serial numbers added: 55899BG,  55900BG,  55901BG,  55902BG  55904BG.

Hematology and Pathology Devices

2

No

US and Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania Vietnam, , United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, Luxembourg.

CELL-DYN Ruby System: || List Number: 08H6701; || Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories

Serial No. 34001BG - 34965BG

Hematology and Pathology Devices

2

No

Worldwide Distribution

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.

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 34857BG 34858BG 34859BG 34869BG 34871BG 34875BG 34889BG 34892BG 34894BG 34895BG 34896BG 34897BG 34915BG 34918BG 34919BG 34923BG 34924BG 34925BG 34926BG 34927BG 34928BG 34929BG 34930BG 34931BG 34941BG 34943BG 34944BG 34945BG 34946BG 34947BG 34957BG 34073BG 34075BG 34085BG 34088BG 34106BG 34131BG 34135BG 34143BG 34144BG 34146BG 34156BG 34159BG 34161BG 34165BG 34183BG 34192BG 34193BG 34196BG 34200BG 34202BG 34205BG 34206BG 34207BG 34208BG 34255BG 34256BG 34259BG 34299BG 34319BG 34343BG 34379BG 34380BG 34381BG 34383BG 34392BG 34401BG 34403BG 34407BG 34411BG 34423BG 34427BG 34428BG 34430BG 34443BG 34446BG 34447BG 34450BG 34458BG 34461BG 34486BG 34489BG 34513BG 34517BG 34519BG 34520BG 34521BG 34547BG 34549BG 34553BG 34555BG 34556BG 34573BG 34574BG 34575BG 34582BG 34588BG 34601BG 34602BG 34605BG 34612BG 34613BG 34616BG 34626BG 34630BG 34632BG 34654BG 34677BG 34678BG 34681BG 34683BG 34696BG 34699BG 34708BG 34747BG 34749BG 34757BG 34764BG 34772BG 34775BG 34776BG 34777BG 34779BG 34796BG 34797BG 34798BG 34803BG 34810BG 34811BG 34812BG 34814BG 34817BG 34819BG 34820BG and 34847BG.

Hematology and Pathology Devices

2

No

Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela.

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

List Number 08H67-01; lot numbers: 35678BG, 35682BG to 35759BG, 35761BG to 35768BG, 35771BG, 34163BG, 34283BG, 34090BG, and 34862BG.

Hematology and Pathology Devices

2

No

Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.

CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. || Abbott Diagnostics Division, Santa Clara, CA 05054