FDA-Device2019-01-02Class II
Alinity i TSH Reagent Kit, List Number 07P4830
Abbott Ireland Diagnostics Division
Hazard
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Sold states
AR, FL, GA, MD, OK, VA
Affected count
678 units
Manufactured in
Lisnamuck, Co. Longford, Ireland
Products
Alinity i TSH Reagent Kit, List Number 07P4830
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2019Don't want to check this manually?
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