ARCHITECT HAVAB G Reagent Kit recalled over hepatitis A risk

Recall date

March 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Abbott Gmbh & Co. KG recalls ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

Recall number

Z-1728-2020

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

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.

Why it was recalled

An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.