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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 02, 2005
Date Posted June 04, 2005
Recall Status1 Terminated 3 on March 16, 2012
Recall Number Z-0873-05
Recall Event ID 31971
Product Classification Radioimmunoassay, Human Growth Hormone - Product Code CFL
Product Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)
Code Information All codes
Recalling Firm/
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente CA 92673-6316
For Additional Information Contact Robert L. Schmidt
Manufacturer Reason
for Recall
Under recovery of diluted samples by as much as 20%.
FDA Determined
Cause 2
Action Recall letter was sent 5/2/2005 which requests return of the product, a response card was included.
Quantity in Commerce undetermined
Distribution Nationwide and to Germany, Sweden, Italy, japan, Spain
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.