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U.S. Department of Health and Human Services

Class 3 Device Recall AIAPack BHCG Calibration Verification Test Set

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  Class 3 Device Recall AIAPack BHCG Calibration Verification Test Set see related information
Date Initiated by Firm June 22, 2007
Date Posted October 03, 2007
Recall Status1 Terminated 3 on October 07, 2010
Recall Number Z-0007-2008
Recall Event ID 38494
510(K)Number K924853-December  
Product Classification in vitro diagnostic - Product Code JJX
Product 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Code Information Catalog # 020661 Lot #G803536 Exp. Date August 2008
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Road
Grove City OH 43123
For Additional Information Contact Charles P. Gill
614-317-1909
Manufacturer Reason
for Recall		 Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Letter, dated July 2, 2006. Immediately examine inventory and quarantine product. If product was further distributed, the direct accounts are to notify their customers including a copy of the original recall letter and Notification of Recall response card.
Quantity in Commerce 47 Boxes
Distribution Nationwide.
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.
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