FDA recall Z-1728-2020

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-03-09

Report date

2020-04-29

Termination date

2021-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wiesbaden, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2020