FDA-Device2019-01-02Class II
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
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
760 units
Manufactured in
Lisnamuck, Co. Longford, Ireland
Products
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2019Don't want to check this manually?
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