Recall Z-0961-03 ยท LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Zeus Scientific Inc
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
| Date | Jul 2, 2003 (initiated Mar 19, 2001) |
| Status | Terminated |
| Reason | Mix-up between low positive and negative controls. |
| Root cause | Other |
| Action | Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus. |
| Quantity | 15 kits |
| Distribution | NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.