Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
FDA device recall Z-1156-04 · posted 2004-07-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
- Root cause
- Other
- Status
- Terminated
- Product code
- MSS
- Quantity affected
- 5275
- Date initiated
- 2003-08-18
- Date posted
- 2004-07-23
- Date terminated
- 2004-08-30
- 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 HEMOGLOBIN A1C REAGENT (K010748) | Beckman Coulter, Inc. | 2001-07-10 |
| SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT (K973696) | Beckman Instruments, Inc. | 1997-11-24 |