Recall Z-0263-05 ยท DHA System, Test, Human Chorionic Gonadotropin
DPC Cirrus
Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
| Date | Nov 30, 2004 (initiated Oct 29, 2004) |
| Status | Terminated |
| Reason | Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'. |
| Root cause | Other |
| Action | The firm faxed the technical bulletin notification to each domestic customer on 10/22/2004. International customers were e-mailed and faxed on the same day. |
| Quantity | 17 UNITS |
| Distribution | The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp., Dec 12, 2003 |