Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Brand
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany is recalling ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. due to An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026