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Beckman Coulter, Inc. · Model OSR61205 · UDI-DI 15099590011925
JMO
Prescription
1
510(k) clearances
0
Adverse events
7
Recalls
33
Facilities
Description
UIBC
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Diagnostics, Inc. | The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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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Get your free API keyRead the docsData 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.