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UIBC-SL

SEKISUI DIAGNOSTICS, LLC · Model 153-90 · UDI-DI 00628063400935

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510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2025-06-26	Beckman Coulter Inc.	Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e.,
2024-05-14	Ortho-Clinical Diagnostics, Inc.	Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer
2020-08-18	Beckman Coulter Inc.	The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
2016-05-24	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect c
2012-12-20	Siemens Healthcare Diagnostics, Inc.	The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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 To
2009-12-16	Siemens Healthcare Diagnostics, Inc.	Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.
2008-03-14	Diagnostic Chemicals, Ltd.	Precipitate in product may cause elevated background absorbance interference.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.