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.
Reported: March 20, 2013 Initiated: December 20, 2012 #Z-0933-2013
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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 19, 503 cartons
- Distribution
- Nationwide Distribution
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 19, 503 cartons.
Why was this product recalled? ▼
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2013. Severity: Low. Recall number: Z-0933-2013.
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