Recall Z-0933-2013— Siemens Healthcare Diagnostics, Inc.
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-12-20, terminated 2014-08-26. It names one FDA 510(k) clearance: K994115. 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.. Reason: The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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)..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-12-20
- Terminated
- 2014-08-26
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.