Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
FDA device recall Z-0404-03 · posted 2002-12-31 · Terminated
Recall details
- Recalling firm
- Elan Diagnostics, Inc.
- Reason for recall
- Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery
- Action taken
- The firm notified Distributors by telephone on 11/4/02 and end-users by Certified Mail on 11/4/02. Distributors and End-users are requested to dispose of product and return label for replacement product.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHH
- Quantity affected
- 170 Kits
- Distribution
- Nationwide
- Date initiated
- 2002-11-07
- Date posted
- 2002-12-31
- Date terminated
- 2012-05-15
- Location
- Smithfield, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHOLESTEROL (K880237) | Tech-Neal Scientific, Inc. | 1988-04-28 |