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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension IBCT Flex Reagent Cartridge

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 Class 3 Device Recall Dimension IBCT Flex Reagent Cartridgesee related information
Date Initiated by FirmDecember 16, 2009
Date PostedSeptember 08, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall NumberZ-2385-2010
Recall Event ID 54460
510(K)NumberK994115 
Product Classification Ferrozine (colorimetric) iron binding capacity - Product Code JMO
ProductDimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.
Code Information Catalog number df84
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information ContactAnne Lara
302-631-6311
Manufacturer Reason
for Recall		Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSiemens issued an "Urgent Field Safety Notice" letter dated December 2009 to users identifying the issue and affected product. Customers were instructed not to use heparinized plasma samples for IBCT testing. IBCT Instructions for Use (IFU) has been updated to reflect that heparinized plasma is no longer an acceptable sample type. Beginning with lot ED0341, the new IFU will be packaged in the carton with the IBCT Flex reagent cartridges. Consignees were requested to forward the notification letter to anyone to whom the product was distributed. The Siemens Technical Solutions Center can be contacted at 800-441-9250.
Quantity in Commerceunknown - all lots involved
DistributionWorldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.
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 = JMO
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