Class 2 Device Recall

• Date Initiated by Firm: March 25, 2005
• Date Posted: May 10, 2005
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-0809-05
• Recall Event ID: 31493
• 510(K)Number: K861797
• Product Classification: Radioimmunoassay, Parathyroid Hormone - Product Code CEW
• Product: Nichols IRMA Intact PTH Assay, catalog No. 40-2171
• Code Information: Lots 40-504553/4 released March 4, 2005 and kit lots 40-501687/8 released March 18, 2005
• FEI Number: 2050095
• Recalling Firm/ Manufacturer: Nichols Institute Diagnostics; 1311 Calle Batido; San Clemente CA 92673-6316
• For Additional Information Contact: Robert Schmidt; 949-940-7417
• Manufacturer Reason for Recall: Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
• FDA Determined Cause: Other
• Action: Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit.
• Quantity in Commerce: Not divulged
• Distribution: Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel
• 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