Abbott Gmbh & Co. KG: Medical Device Recall in 2020 - (Recall #: Z-1728-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 9, 2020

Date Posted: April 29, 2020

Recall Number: Z-1728-2020

Event ID: 85238

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.

Status: Terminated

Product Quantity: 7,347 kits

Code Information:

List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated