Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
FDA device recall Z-0263-05 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- DPC Cirrus
- Reason for recall
- Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHA
- Quantity affected
- 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, Netherlan
- Date initiated
- 2004-10-29
- Date posted
- 2004-11-30
- Date terminated
- 2005-01-18
- Location
- Flanders, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (K033234) | Diagnostic Products Corp. | 2003-12-12 |