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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 June 20, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on August 30, 2005
Recall Number Z-1422-05
Recall Event ID 32714
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Product STA-R blood coagulation analyzer. Catalog Number 57160.
Code Information All units distributed under Catalog Number 57160.
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact James Barrow
973-631-1200
Manufacturer Reason
for Recall		 Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.
FDA Determined
Cause 2		 Other
Action Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned.
Quantity in Commerce 215 units
Distribution Units were distributed to clinics and hospitals 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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