Device Recall CELLDYN

  • Model / Serial
    Model Numbers: 92161-02 and 06H54-01 for the Waste Line Assembly; 02H96-01 for the Waste Outlet Tubing; and 03H98-02 for the Waste Bottle Cable.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Thailand, Trinidad and Tobago, and Uruguay.
  • Product Description
    The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. || Usage: Accessories to human waste container systems
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA

26 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot 6853, Expiration date: 31 JUL2017; Lot 6901, Expiration date: 31JUL2017; Lot 6953, Expiration date: 30SEP2017;   May 4, 2016 - Firm advised SAN-DO that it has expanded the recall to include three additional lots:  Lot 6991, Expiration date: 30NOV2017; Lot 7024, Expiration date: 31DEC2017; Lot: 7027, Expiration date: 31DEC2017.  June 28, 2016 - firm added an additional 4 lots to recall: Lot 7044, expiration date 31JAN2018; Lot 7082, expiration date 28FEB2018; Lot 7110, expiration date 31MAR2018; Lot 7119, expiration date 30APR2018.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Manufacturer
  • Model / Serial
    List Number: 07H22-01, lot numbers: 16328 and 29401
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
  • Product Description
    CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
  • Manufacturer
  • Model / Serial
    Lot Numbers: 10916I2, 10917I2,  10918I2,  10919I2,  10920I2,  10921I2
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, lA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. and countries of Australia, Argentina, Brazil, Hong Kong, Japan, Korea, Malaysia, Singapore.
  • Product Description
    CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: || Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Manufacturer
  • Model / Serial
    Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.
  • Product Description
    CELL-DYN 4000 Diluent/Sheath Reagent, || List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Manufacturer
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