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Abbott Laboratories recalls CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is design
Recalled April 27, 2016 · FDA recall Z-1522-2016 · Abbott Laboratories
Hazard
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. · FDA Class II
Units
10,364 plus 9410 additional units for recall expansion.
Sold at
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.
Description
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.
Product
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(s)
Abbott Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →