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/ 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 |
Under recovery of diluted samples by as much as 20%.
|
FDA Determined Cause 2 |
Other |
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
|
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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.
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