FDA-Device2020-04-29Class II
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
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.
Sold states
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.
Affected count
7,347 kits
Manufactured in
Max-Planck-Ring 2, 65205, Wiesbaden, N/A, Germany
Products
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2020Don't want to check this manually?
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