FDA-Device2022-09-07Class II
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Abbott Laboratories
Hazard
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Sold states
Nationwide
Affected count
2451 kits of 100 tests
Manufactured in
100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, United States
Products
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1660-2022Don't want to check this manually?
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