Recall Z-1047-04 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
bioMerieux
VIDAS CMV IgG Assay
| Date | Jul 20, 2004 (initiated Jun 9, 2004) |
| Status | Terminated |
| Reason | The product may give false positive results. |
| Root cause | Other |
| Action | Consignees were notified by letter on June 9, 2004. |
| Quantity | 148 units |
| Distribution | AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920661 | VIDAS CMV IGG ASSAY Vitek Systems, Inc., Feb 12, 1993 |