Recall Z-1689-2016 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Diamedix Corporation
Diamedix Is-CMV IgG Test Kit
| Date | Mar 26, 2015 |
| Status | Terminated |
| Reason | Product contained an incorrect substrate. |
| Root cause | Other |
| Action | On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit. |
| Quantity | 150 kits |
| Distribution | AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM Diamedix Corp., Sep 21, 1998 |