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.
Recall
- Recall Number
- Z-0933-2013
- Event Number
- 64063
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- JMO
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- December 20, 2012
- Posted
- March 11, 2013
- Terminated
- August 26, 2014
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466
Description
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.
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
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sensitivity of 6 ug/dL (1.1 umol/L) in the Dimension(R) IBCT FLex(R) Reagent Cartridge instructions for us (IFU) is no longer valid.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.
Nationwide Distribution
19, 503 cartons