Abbott Laboratories HPD/ADD/GPRD Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
List 7C18-20, 4 x 100 test kit, lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004, and list 7C18-25, 100 test kit, lot 07779M301, exp 06/19/2004
Products Sold
List 7C18-20, 4 x 100 test kit, lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004; and list 7C18-25, 100 test kit, lot 07779M301, exp 06/19/2004
Abbott Laboratories HPD/ADD/GPRD is recalling Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diag due to Aspiration errors in the conjugate component due to microbial contamination of the conjugate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
Recommended Action
Per FDA guidance
Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 11/5/03 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the aspiration errors in the conjugate component and were instructed to discontinue use and destroy any of the affected lots remaining.
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