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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 14, 2005
Date PostedOctober 15, 2005
Recall Status1 Terminated 3 on March 16, 2012
Recall NumberZ-0056-06
Recall Event ID 31917
Product Classification Radioimmunoassay, Parathyroid Hormone - Product Code CEW
ProductNichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.
Code Information Lot 62-402651
FEI Number 2050095
Recalling Firm/
Manufacturer		 Nichols Institute Diagnostics
1311 Calle Batido
San Clemente CA 92673-6316
For Additional Information ContactRobert L. Schmidt
949-940-7417
Manufacturer Reason
for Recall		Controls were out of specification range.
FDA Determined
Cause 2		Other
ActionRecall letter and response form was sent on April 14, 2005 to all domestic and foreign consignees.
Quantity in Commerce323
DistributionNationwide, Japan, Spain, Germany and Sweden
Total Product Life CycleTPLC 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.
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