Recall Z-1313-06 ยท DHX System, Test, Carcinoembryonic Antigen
Beckman Coulter Inc
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
| Date | Aug 1, 2006 (initiated Apr 12, 2006) |
| Status | Terminated |
| Reason | Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens. |
| Root cause | Other |
| Action | A Product Corrective Action letter was sent via US mail the week of April 10, 2006 to all Access CEA customers informing them that the Access CEA Assay could generate decreased values with certain frozen patient specimens. Although they have found it at a low occurrence, it is recommended that specimens should not be frozen prior to analysis until further notice. The letter informs customers that Beckman Coulter has verified sample stability through at least 14 days when properly stored at 2-8 degrees Celsius and shipping stability for 4 days at 2-8 degrees Celsius using cool packs. Firm |
| Quantity | 775 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 Beckman Coulter, Inc., Sep 24, 1998 |