LDL Cholesterol Reagent (LDLD) Part No. 969706
FDA device recall Z-1099-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRR
- Quantity affected
- 291
- Date initiated
- 2003-02-10
- Date posted
- 2004-07-20
- Date terminated
- 2004-12-02
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR (K014103) | Beckman Coulter, Inc. | 2002-01-28 |