Recall Z-1127-03 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Meridian Bioscience Inc
Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
| Date | Aug 12, 2003 (initiated Jun 18, 2003) |
| Status | Terminated |
| Reason | The Low Positive Standard kit component is losing potency that may result in false positive test results. |
| Root cause | Other |
| Action | The firm notified their customers by telephone and fax on 6/18/2003. |
| Quantity | 43 kits |
| Distribution | The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924096 | CMV ELISA TEST SYSTEM Zeus Scientific, Inc., Apr 2, 1993 |