Class 2 Device Recall

• Date Initiated by Firm: April 07, 2005
• Date Posted: May 10, 2005
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-0810-05
• Recall Event ID: 31730
• 510(K)Number: K033727
• Product Classification: Radioimmunoassay, Parathyroid Hormone - Product Code CEW
• Product: Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
• Code Information: Lots 62-402598 and 62-402622
• FEI Number: 2050095
• Recalling Firm/ Manufacturer: Nichols Institute Diagnostics; 1311 Calle Batido; San Clemente CA 92673-6316
• Manufacturer Reason for Recall: Values do not agree with Directional Instructions.
• FDA Determined Cause: Other
• Action: Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s.
• Quantity in Commerce: 13751
• Distribution: Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, 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 = CEW