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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 FirmApril 13, 2010
Date PostedSeptember 11, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall NumberZ-2400-2010
Recall Event ID 55610
510(K)NumberK051650 
Product Classification Immunoassay Method, Troponin Subunit - Product Code MMI
ProductStratus CS Acute Care Troponin I TestPak ( Troponin I assay)
Code Information lot# 239229002, EXP# 2/13/2010  lot# 239236002, EXP2/20/2010  lot# 239243002, EXP# 2/7/2010 lot# 239257002, EXP# 3/10/2010 lot# 239264002, EXP# 3/20/2010 lot# 239271002, EXP# 3/27/2010 lot# 239278002, EXP# 4/3/2010 lot# 239285002, EXP# 4/10/2010 lot# 239292002, EXP# 4/17/2010 lot# 239299002, EXP# 4/24/2010 lot# 239313002, EXP 5/8/2010 lot# 239334002, EXP 5/29/2010 lot# 239341002, EXP#6/5/2010 lot# 239362002, EXP# 6/26/2010
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information ContactSiemens Customer Service Center
800-405-6473
Manufacturer Reason
for Recall		False elevated Stratus CS CTNI results
FDA Determined
Cause 2		Process control
ActionRecalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.
Quantity in Commerce7500 cartons
DistributionNationwide Distribution
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 = MMI
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