BEUDAMED
    FDA Recall Terminated

    CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.

    Recall: Z-1522-2016 · Initiated March 24, 2016

    Recall

    Recall Number
    Z-1522-2016
    Event Number
    73655
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 24, 2016
    Posted
    April 19, 2016
    Terminated
    January 4, 2017
    Address
    4551 Great America Pkwy, Santa Clara, CA, 95054-1208

    Description

    CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.

    Reason

    Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.

    Action

    All customers who were shipped the affected lots were sent a Product Recall letter on March 24, 2016 via Federal Express. Letters were titled Product Recall - Immediate Action Required. An additional four lots were discovered to be affected by the recall and the firm send letters to customers affected by these lots on June 27, 2016

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, Italy, Canada, Vietnam, Singapore, Argentina, Colombia, France, Paraguay, Australia, Uruguay, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Ethiopia, Finland, Greece, Switzerland, United Kingdom, Brazil, Hong, Kong, Hungary, India, Ireland, Israel, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Turkey, Jamaica, St. Martin, Nigeria, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Guatemala, Peru, and Uruguay.

    Quantity

    10,364 plus 9410 additional units for recall expansion.