FDA-Device2019-10-30Class II
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Abbott Laboratories
Hazard
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
Sold states
Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.
Affected count
22 analyzers with tubing
Manufactured in
4551 Great America Pkwy, Santa Clara, CA, United States
Products
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2020Don't want to check this manually?
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