Reported Mar 20, 2013 · Terminated
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to…
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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.
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published DF84Siemens Material Number (SMN) 10444944, -- 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 - Amount recalled
- 19, 503 cartons
Where it was sold
- Nationwide
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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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