FDA Medical Device Recalls (openFDA)
Elan Diagnostics, Inc.: Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
- Recall number
- Z-0404-03
- Recalling firm
- Elan Diagnostics, Inc.
- Product
- Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
- Status
- Terminated
- Initiated
- 2002-11-07
- Posted
- 2002-12-31
- Terminated
- 2012-05-15
- 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
- Lot, serial or model codes
- Lot Number: 2030000 Exp.Date: 11/30/03
- 510(k) numbers
- ["K880237"]
- PMA numbers
- not on file
- Product code
- CHH
- Firm FEI
- 1221157
- Firm city
- Smithfield
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28