Recall Z-1065-03 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Zeus Scientific Inc
Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
| Date | Jul 30, 2003 (initiated Feb 24, 2000) |
| Status | Terminated |
| Reason | The high positive control/low positive standard ratio recovering too low. |
| Root cause | Other |
| Action | Recall letters sent out via DHL on 2/24/2000 |
| Quantity | 205 |
| Distribution | The two lots were shipped to St. Louis, MO. No subrecall was initiated. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM Zeus Scientific, Inc., Jul 20, 1999 |