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U.S. Department of Health and Human Services

Class 2 Device Recall Stratus CS Acute Care Troponin I TestPak

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 Class 2 Device Recall Stratus CS Acute Care Troponin I TestPaksee related information
Date Initiated by FirmJune 23, 2008
Date PostedJanuary 28, 2009
Recall Status1 Terminated 3 on January 29, 2009
Recall NumberZ-0668-2009
Recall Event ID 49711
510(K)NumberK051650 
Product Classification in vitro diagnostic - Product Code JHX
ProductStratus 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
For Additional Information ContactSiemens Customer Service Center
800-241-0420
Manufacturer Reason
for Recall		Incorrect result: Potential for false elevation of CTnI results
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSiemens 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 Commerce5868 cartons
DistributionWorldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
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.
510(K) Database510(K)s with Product Code = JHX
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