Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
This recall has been terminated (originally issued December 31, 2002).
- Company
- Elan Diagnostics, Inc.
- Recall Initiated
- November 7, 2002
- Posted
- December 31, 2002
- Terminated
- May 15, 2012
- Recall Number
- Z-0404-03
- Quantity
- 170 Kits
- Firm Location
- Smithfield, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery
Distribution
Nationwide
Lot / Code Info
Lot Number: 2030000 Exp.Date: 11/30/03
Root Cause
Other
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.