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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge

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  Class 3 Device Recall Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge see related information
Date Initiated by Firm December 20, 2012
Date Posted March 11, 2013
Recall Status1 Terminated 3 on August 26, 2014
Recall Number Z-0933-2013
Recall Event ID 64063
510(K)Number K994115  
Product Classification Ferrozine (colorimetric) iron binding capacity - Product Code JMO
Product Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge.

An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
Code Information Siemens Material Number (SMN) 10444944, Catalog number DF84 -- lot numbers BA3016, EXP 2013-01-16; EC3045, EXP 2013-02-14; EA3073, EXP 2013-03-14; DC3102, EXP 2013-04-12; FC3122, EXP 2013-05-02; EA3157, EXP 2013-06-06; BB3184, EXP 2013-07-03; EC3219, EXP 2013-08-07; EC3220, EXP 2013-08-08; GA3248, 2013-09-05; and FB3290, EXP 2013-10-17
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
Manufacturer Reason
for Recall
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).
FDA Determined
Cause 2
Process design
Action Siemens Healthcare sent a "Urgent Medical Device Correction" letter dated Dec 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified that theanalytical sensitivity of 6 ug/dL (1.1 umol/L) in the Dimension(R) IBCT FLex(R) Reagent Cartridge instructions for us (IFU) is no longer valid. Please make adjustments to middle wave products or Laboratory Information Systems ( LIS ) as appropriate for your Laboratory. Please complete the attached form and fax it to (302) 631-8467, to indicate you have received this information. If you have any questions please contact your Siemens Technical Solutions Center or your local Siemens technicial support representative at (302) 631-6311.
Quantity in Commerce 19, 503 cartons
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JMO and Original Applicant = DADE BEHRING, INC.