Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Immunology · 21 CFR 866.5270
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Recent MDR events
18 adverse event reports on file
- CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVEJul 31, 2025MalfunctionRoche Diagnostics1823260-2025-02359
- ATELLICA CHApr 11, 2025MalfunctionSiemens Healthcare Diagnostics Inc2432235-2025-00108
- CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVEDec 6, 2024MalfunctionRoche Diagnostics1823260-2024-03554
- CRPHSNov 20, 2023MalfunctionRoche Diagnostics1823260-2023-03696
- CRPHSOct 19, 2023MalfunctionRoche Diagnostics1823260-2023-03350
- CRP LATEX REAGENTMar 18, 2021InjuryBeckman Coulter9680746-2021-00022
- CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVEFeb 26, 2021MalfunctionRoche Diagnostics1823260-2021-00595
- CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVEJul 17, 2017MalfunctionRoche Diagnostics1823260-2017-01472
- CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVENov 15, 2016MalfunctionRoche Diagnostics1823260-2016-01772
- IMMAGE® 800 IMMUNOCHEMISTRY SYSTEMSep 6, 2012MalfunctionBeckman Coulter, Inc.2050012-2012-01710
Event type breakdown
Recalls
3 recall events for this product code
- Roche Diagnostics Operations, Inc.TerminatedJan 24, 2017
Tina-Quant (Latex) HS Test System
Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR ANALYTICS P module. this issue can lead to erroneous low CRPHS results. CRPHS is used as a marker for the prediction of cardiovascular risk. An erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.
Z-1092-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedJan 7, 2016
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Z-0614-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedJan 7, 2016
Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Z-0616-2016 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Beckman Coulter, Inc.
BREA, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Sentinel Ch. Spa
MILANO, IT
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Beckman Coulter, Inc.
CARLSBAD, CA, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Siemens Healthcare Diagnostics Inc
East Walpole, MA, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Abbott Gmbh
Wiesbaden Hesse, DE
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
510(k) clearances
19 clearances for this product code
- Roche DiagnosticsApr 2, 2026
K260026 · Tina-quant Cardiac high sensitivity CRP III
- Siemens Healthcare Diagnostics, Inc.Jan 18, 2024
K233242 · Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
- Siemens Healthcare Diagnostics Products GmbHDec 16, 2022
K212559 · CardioPhase® hsCRP
- SENTINEL CH. SpASep 27, 2018
K173833 · CRP Vario
- Siemens Healthcare Diagnostics, Inc.Jul 29, 2008
K081294 · ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
- Beckman Coulter, Inc.Jun 21, 2007
K071002 · IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
- Beckman Coulter, Inc.May 4, 2007
K070626 · SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
- Siemens Medical Solutions DiagnosticsMay 2, 2007
K071017 · IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)