Recall Z-0404-03 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Elan Diagnostics, Inc.
Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
| Date | Dec 31, 2002 (initiated Nov 7, 2002) |
| Status | Terminated |
| Reason | Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery |
| Root cause | Other |
| Action | 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. |
| Quantity | 170 Kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880237 | CHOLESTEROL Tech-Neal Scientific, Inc., Apr 28, 1988 |