Recall Z-1498-04 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Abbott Laboratories HPD/ADD/GPRD
Architect Anti-HBs Reagent Kit; list 7C18-20, 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
| Date | Sep 30, 2004 (initiated Aug 27, 2004) |
| Status | Terminated |
| Reason | There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots. |
| Root cause | Other |
| Action | 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. |
| Quantity | 6,691 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.