Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0404-03 · Posted 2002-12-31

Recalling FirmElan Diagnostics, Inc.
Recall StatusTerminated
Product CodeCHH
Date Initiated2002-11-07
Date Terminated2012-05-15
Product Quantity170 Kits

Reason for Recall

Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K880237CHOLESTEROLTech-Neal Scientific, Inc. · 1988-04-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑