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.
FDA Recall Z-0933-2013 · Posted 2013-03-11
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJMO
Date Initiated2012-12-20
Date Terminated2014-08-26
Product Quantity19, 503 cartons
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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
Firm 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sensitivity of 6 ug/dL (1.1 umol/L) in the Dimension(R) IBCT FLex(R) Reagent Cartridge instructions for us (IFU) is no longer valid.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.
Root Cause
Process design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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