—#115310

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.

FDA product code: JMO — Ferrozine (Colorimetric) Iron Binding Capacity
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K994115
Affected lot / code info: 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

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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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

Root cause (FDA determination)

Process design

Action the firm took

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sensitivity of 6 ug/dL (1.1 umol/L) in the Dimension(R) IBCT FLex(R) Reagent Cartridge instructions for us (IFU) is no longer valid.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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2012-12-20
Posted by FDA: 2013-03-11
Terminated: 2014-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115310. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.