Recall Z-1015-05 ยท DHX System, Test, Carcinoembryonic Antigen
Diagnostic Products Corp
Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
| Date | Jul 16, 2005 (initiated May 26, 2005) |
| Status | Terminated |
| Reason | Adverse trend in stability, controls biased or out of range. |
| Root cause | Other |
| Action | Recall was initiated by phone using a script, to be followed up with a letter and response form. |
| Quantity | 269 |
| Distribution | Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970877 | IMMULITE CEA Diagnostic Products Corp., Sep 22, 1997 |