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U.S. Department of Health and Human Services

Class 2 Device Recall STA Compact and STA Compact CT

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  Class 2 Device Recall STA Compact and STA Compact CT see related information
Date Initiated by Firm July 30, 2007
Date Posted October 11, 2007
Recall Status1 Terminated 3 on December 17, 2007
Recall Number Z-0039-2008
Recall Event ID 39419
510(K)Number K961579  
Product Classification Haemostasis Analyzer, in vitro diagnostic - Product Code GKP
Product STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Code Information BT7 7016065; BT7 7016067; BT7 7016068; BT7 7016072; BT7 7016074; BT7 7016075; BT8 7016076; BT7 7016078; BT7 7017080; BT7 7016090; BT7 7016091; BT8 7026119; BT8 7026126; BT8 7026127; BT8 7026128; BT8 7026130; BT7 7026134; BT7 7026135; BT7 7026140; BT8 7026146; BT8 7026147; BT8 7026148; BT8 7026149; BT8 7026150; BT7 7026151; BT7 7026152; BT7 7026153; BT7 7026154; BT7 7026155; BT7 7026156; BT7 7026157; BT7 7036164; BT7 7036166; BT7 7036167; BT7 7036168; BT7 7036177; BT7 7036192. 
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact
973-631-1200
Manufacturer Reason
for Recall		 Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.
FDA Determined
Cause 2		 Process design
Action Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
Quantity in Commerce 41 units installed
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.
510(K) Database 510(K)s with Product Code = GKP and Original Applicant = AMERICAN BIOPRODUCTS CO.
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