FDAFDA · Food and drugs·Recall number Z-0933-2013
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.
Published March 20, 2013 · Recall initiated: December 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Nationwide Distribution
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.