Z-0404-03

Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250

Name: Z-0404-03 Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
Creator: Elan Diagnostics, Inc.
Published: 2002-11-07
License: https://open.fda.gov/license/

Elan Diagnostics / initiated 2002-11-07 / Terminated

FDA source

Elan Diagnostics, Inc. began a recall of Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250 on 2002-11-07. The reason FDA records is "Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0404-03
Status: Terminated
Initiated: 2002-11-07
Posted: 2002-12-31
Terminated: 2012-05-15
Recalling firm: Elan Diagnostics
Product: Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery
FDA 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 in commerce: 170 Kits
Distribution: Nationwide
Product codes and lots: Lot Number: 2030000 Exp.Date: 11/30/03

Product code CHH

K880237Class ICholesterolTech-Neal Scientific, Inc. / cleared 1988-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)