Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0933-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: December 20, 2012

Date Posted: March 20, 2013

Recall Number: Z-0933-2013

Event ID: 64063

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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).

Status: Terminated

Product Quantity: 19, 503 cartons

Code Information:

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

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated