Z-1728-2020Class II

ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25

Name: Z-1728-2020 ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25
Creator: Abbott Gmbh & Co. KG
Published: 2020-03-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-03-09 / Terminated / root cause: manufacturing process

FDA source

Abbott Gmbh & Co. KG began a recall of ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25 on 2020-03-09. FDA classified it as Class II and gives the reason as "An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1728-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-09
Posted: 2020-04-17
Terminated: 2021-02-11
Recalling firm: Abbott Medical
Product: ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
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.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots.
Quantity in commerce: 7,347 kits
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1728-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1728-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code LOL

K113704Class IIArchitect Havab-GAbbott Laboratories / cleared 2012-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)