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U.S. Department of Health and Human Services

Class 2 Device Recall 25OH Vitamin D

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  Class 2 Device Recall 25OH Vitamin D see related information
Date Initiated by Firm June 30, 2004
Date Posted February 24, 2005
Recall Status1 Terminated 3 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 2
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 and Original Applicant = NICHOLS INSTITUTE DIAGNOSTICS
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