FDA-Device2022-03-09Class II
Alinity m Integrated Reaction Units (IRU)
Abbott Molecular, Inc.
Hazard
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Sold states
US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
Affected count
3063 kits
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Alinity m Integrated Reaction Units (IRU)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0710-2022Don't want to check this manually?
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