Recall Z-1129-03 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Abbott Laboratories HPD/ADD/GPRD
IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
| Date | Aug 13, 2003 (initiated Jul 22, 2003) |
| Status | Terminated |
| Reason | The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated. |
| Root cause | Other |
| Action | Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03. |
| Quantity | 423 kits |
| Distribution | California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931059 | IMX RUBELLA IGM ANTIBODY ASSAY Abbott Laboratories, Dec 19, 1994 |