Class 2 Device Recall

• Date Initiated by Firm: April 22, 2005
• Date Posted: July 28, 2005
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-1044-05
• Recall Event ID: 32042
• 510(K)Number: K962601
• Product Classification: Radioimmunoassay, Acth - Product Code CKG
• Product: Nichols Advantage ACTH Test System, catalog number 62-7004.
• Code Information: Lot 62-500040 and 62-404296
• FEI Number: 2050095
• Recalling Firm/ Manufacturer: Nichols Institute Diagnostics; 1311 Calle Batido; San Clemente CA 92673-6316
• Manufacturer Reason for Recall: Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
• FDA Determined Cause: Other
• Action: Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.
• Quantity in Commerce: 1203
• Distribution: Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CKG