System, Test, C-reactive Protein
Immunology · 21 CFR 866.5270
Recent MDR events
50 adverse event reports on file
- TINA-QUANT C-REACTIVE PROTEIN IVJul 22, 2026MalfunctionRoche Diagnostics1823260-2026-02962
- TINA-QUANT C-REACTIVE PROTEIN IVJun 29, 2026MalfunctionRoche Diagnostics1823260-2026-02578
- TINA-QUANT C-REACTIVE PROTEIN IVJun 29, 2026MalfunctionRoche Diagnostics1823260-2026-02583
- TINA-QUANT C-REACTIVE PROTEIN IVJun 12, 2026MalfunctionRoche Diagnostics1823260-2026-02335
- TINA-QUANT C-REACTIVE PROTEIN IVApr 23, 2026InjuryRoche Diagnostics1823260-2026-01559
- TINA-QUANT C-REACTIVE PROTEIN IFeb 19, 2026MalfunctionRoche Diagnostics1823260-2026-00592
- TINA-QUANT C-REACTIVE PROTEIN IVFeb 11, 2026MalfunctionRoche Diagnostics1823260-2026-00475
- TINA-QUANT C-REACTIVE PROTEIN IVNov 19, 2025MalfunctionRoche Diagnostics1823260-2025-04702
- TINA-QUANT C-REACTIVE PROTEIN IVOct 30, 2025MalfunctionRoche Diagnostics1823260-2025-04422
- TINA-QUANT C-REACTIVE PROTEIN IVSep 25, 2025MalfunctionRoche Diagnostics1823260-2025-03671
Event type breakdown
Recalls
5 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedApr 10, 2025
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Z-1551-2025 · View FDA record ↗ - The Binding Site Group, Ltd.TerminatedMar 31, 2020
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
Z-1619-2020 · View FDA record ↗ - The Binding Site Group, Ltd.TerminatedDec 12, 2019
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive p
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Z-0671-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedSep 8, 2009
Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP).
falsely elevated results in EDTA plasma samples
Z-1930-2009 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedUnknown
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roc
Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Z-0634-2021 · View FDA record ↗
Registered firms
52 firms currently registered for this product code
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Nano-ditech Corporation
Cranbury, NJ, US
Nipro Corporation Odate Factory
ODATE-SHI Akita, JP
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Diamond Diagnostics Inc.
Budapest, HU
Stanbio Laboratory
Boerne, TX, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Cliniqa Corporation
San Marcos, CA, US
Phc Corporation
Chiyoda-ku Tokyo, JP
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Phc Corporation
Tako-machi Katori-gun Chiba, JP
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
The Binding Site
Kings Norton Birmingham, GB
Randox Laboratories Limited
ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Monobind, Inc.
Lake Forest, CA, US
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, Llc.
CORTLANDT MANOR, NY, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Abaxis, Inc.
UNION CITY, CA, US
510(k) clearances
70 clearances for this product code
- Siemens Healthcare Diagnostic Products GmbHNov 27, 2023
K232624 · CardioPhase® hsCRP
- Siemens Healthcare Diagnostics, Inc.Mar 17, 2023
K221119 · RCRP Flex reagent cartridge
- Roche Diagnostics Operations (Rdo)Feb 21, 2020
K192072 · Tina-quant C-Reactive Protein IV
- The Binding Site Group , Ltd.Oct 12, 2018
K180099 · Optilite High Sensitivity C-Reactive Protein Kit
- The Binding Site Group , Ltd.Feb 28, 2018
K172868 · Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
- Meso Scale Diagnostics, LLCJan 12, 2018
K171498 · MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
- The Binding Site GroupApr 5, 2017
K161982 · C-Reactive Protein Kit for use on SPAPLUS
- Hitachi Chemical Diagnostics, Inc.Aug 17, 2012
K113809 · HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)