| Class 3 Device Recall Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge |  |
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
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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/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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For Additional Information Contact | 302-631-6311 |
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Reason for Recall | The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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sensitivity of 6 ug/dL (1.1 umol/L) in the Dimension(R) IBCT FLex(R) Reagent Cartridge instructions for us (IFU) is no longer valid.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 |
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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.
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510(K) Database | 510(K)s with Product Code = JMO
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