Abbott Laboratories HPD/ADD/GPRD Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 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 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 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, lots 10014M200, 08672M200, 07780M300 and 17048M100, list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101, list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100
Products Sold
list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100
Abbott Laboratories HPD/ADD/GPRD is recalling Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18- due to There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
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 8/27/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for significant differences in quantitative results for certain specimens 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