Z-0209-04

Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics...

Name: Z-0209-04 Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-11-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-05 / Terminated / root cause: sterility

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of 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... on 2003-11-05. The reason FDA records is "Aspiration errors in the conjugate component due to microbial contamination of the conjugate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0209-04
Status: Terminated
Initiated: 2003-11-05
Posted: 2003-12-11
Terminated: 2004-07-20
Recalling firm: Abbott Medical
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
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
Root cause tag: sterility
FDA root cause: Other
Action: 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.
Quantity in commerce: 2,244 kits
Distribution: Canada, Japan, Australia, New Zealand, Germany and England
Product codes and lots: 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

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)