Recall Z-0801-03 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Abbott Laboratories HPD/ADD
Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
| Date | May 9, 2003 (initiated Apr 7, 2003) |
| Status | Terminated |
| Reason | Particulate matter in the microparticle component. |
| Root cause | Other |
| Action | Abbott affiliates in Canada, Germany and Japan were faxed copies of the recall letter on 4/7/03 for translation where needed and dissemination to their accounts receivin the suspect lot. The end users were advised of the mold-microparticle aggregation and instructed to discontinue use and destroy any of the lot remaining. |
| Quantity | 289 kits |
| Distribution | Canada, Germany and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.