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U.S. Department of Health and Human Services

Class 2 Device Recall The Dimension TNI Flex reagent cartridge

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 Class 2 Device Recall The Dimension TNI Flex reagent cartridgesee related information
Date Initiated by FirmApril 12, 2010
Date PostedNovember 24, 2010
Recall Status1 Terminated 3 on March 19, 2013
Recall NumberZ-0460-2011
Recall Event ID 55604
510(K)NumberK081643 
Product Classification Immunoassay method, troponin subunit - Product Code MMI
ProductThe Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Code Information Lot# FD0110 Exp# 04/20/2010, Lot#FD0141, EXP# 05/21/2010, Lot# ED0155, EXP# 06/04/2010, Lot# EA0227, EXP# 08/15/2010, Lot# EB0247, EXP#09/04/2010, Lot# FA2096, EXP#10/23/2010, Lot#FC0310, EXP# 11/06/2010, Lot# FA0330, EXP# 11/26/2010.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information ContactTechnical Solutions
800-441-9250
Manufacturer Reason
for Recall		Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.
FDA Determined
Cause 2		Other
ActionSiemens issued an "Urgent Field Safety Notice" dated April 2010, informing users of the problem and instructing them to inspect cartridges for leaking fluid. Cartridges with leaking fluid should be reported to the Siemens Technical Solutions Center. The Technical Solutions Center can be contacted at 800 441 9250.
Quantity in Commerce4966
DistributionWorldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
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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