Recall Z-1095-03 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Zeus Scientific Inc
Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
| Date | Aug 12, 2003 (initiated Jun 12, 2003) |
| Status | Terminated |
| Reason | The Calibrator included within the kit may be losing reactivity. |
| Root cause | Other |
| Action | All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed. |
| Quantity | 270 kits |
| Distribution | The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891081 | CMV ELISA TEST SYSTEM Zeus Scientific, Inc., Jun 2, 1989 |