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Beckman Coulter, Inc. · Model OSR6170 · UDI-DI 15099590010676

CEK Prescription
10
510(k) clearances
93
Adverse events
10
Recalls
43
Facilities

Description

Urinary/CSF Protein

Recalls

DateFirmReason
2025-08-11Siemens Healthcare Diagnostics, Inc.Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
2024-07-29Siemens Healthcare Diagnostics, Inc.The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
2024-07-29Siemens Healthcare Diagnostics, Inc.The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
2023-01-27Siemens Healthcare Diagnostics, Inc.Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
2021-09-20Siemens Healthcare Diagnostics, Inc.The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsel
2021-09-20Siemens Healthcare Diagnostics, Inc.The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely de
2020-12-15Ortho Clinical Diagnostics IncEltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
2020-12-15Ortho Clinical Diagnostics IncEltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
2013-06-12Ortho-Clinical DiagnosticsOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
2003-03-26Ortho-Clinical DiagnosticsSlides may exhibit random, elevated imprecision of results.

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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.