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Class 2 Device Recall Stratus CS Acute Care Troponin I TestPak |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
June 23, 2008 |
Date Posted |
January 28, 2009 |
Recall Status1 |
Terminated 3 on January 29, 2009 |
Recall Number |
Z-0668-2009 |
Recall Event ID |
49711 |
510(K)Number |
K051650
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Product Classification |
in vitro diagnostic - Product Code JHX
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Product |
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. |
Code Information |
Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15. |
Recalling Firm/ Manufacturer |
Dade Behring, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
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For Additional Information Contact |
Siemens Customer Service Center 800-241-0420
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Manufacturer Reason for Recall |
Incorrect result: Potential for false elevation of CTnI results
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge. |
Quantity in Commerce |
5868 cartons |
Distribution |
Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India. |
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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510(K) Database |
510(K)s with Product Code = JHX and Original Applicant = DADE BEHRING, INC.
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