Home / Recalls / Medical Devices
Abbott Gmbh & Co. KG recalls ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Recalled April 29, 2020 · FDA recall Z-1728-2020 · Abbott Gmbh & Co. KG
Hazard
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots. · FDA Class II
Units
7,347 kits
Sold at
US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.
Description
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Product
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Manufacturer(s)
Abbott Gmbh & Co. KG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →