Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
FDA device recall Z-1015-05 · posted 2005-07-16 · Terminated
Recall details
- Recalling firm
- Diagnostic Products Corp
- Reason for recall
- Adverse trend in stability, controls biased or out of range.
- Action taken
- Recall was initiated by phone using a script, to be followed up with a letter and response form.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHX
- Quantity affected
- 269
- Distribution
- Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.
- Date initiated
- 2005-05-26
- Date posted
- 2005-07-16
- Date terminated
- 2006-02-03
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE CEA (K970877) | Diagnostic Products Corp. | 1997-09-22 |