Recall Z-0209-04 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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
| Date | Dec 11, 2003 (initiated Nov 5, 2003) |
| Status | Terminated |
| Reason | Aspiration errors in the conjugate component due to microbial contamination of the conjugate. |
| 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 | 2,244 kits |
| Distribution | Canada, Japan, Australia, New Zealand, Germany and England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.