Class 2 Device Recall 25OH Vitamin D

• Date Initiated by Firm: June 30, 2004
• Date Posted: February 24, 2005
• Recall Status: Terminated on February 10, 2012
• Recall Number: Z-1118-04
• Recall Event ID: 29504
• 510(K)Number: K012367
• Product Classification: System, Test, Vitamin D - Product Code MRG
• Product: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
• Code Information: Not limited to specific lots.
• Recalling Firm/ Manufacturer: Nichols Institute Diagnostics; 1311 Calle Batido; San Clemente CA 92673-6316
• For Additional Information Contact: Robert L. Schmidt; 949-940-7417
• Manufacturer Reason for Recall: Lower than expected results are obtained.
• FDA Determined Cause: Other
• Action: Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.
• Quantity in Commerce: Not Applicable.
• Distribution: Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.
• 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 = MRG