Home › Device types › DCK
C-Reactive Protein, Antigen, Antiserum, And Control
FDA product code DCK · Class 2 · Immunology
92
Registered devices
7
Adverse events
17
Recalls
126
510(k) clearances
Devices with this code
Atellica CH CRP_2 — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.CRP Titer Control — BIOKIT, S.A.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.CRP — RANDOX LABORATORIES LIMITEDARCHITECT — ABBOTT LABORATORIESProciseDx Analyzer — Chembio Diagnostic Systems Inc.CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049 — CAROLINA LIQUID CHEMISTRIES CORPORATIONClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP) — CLEARCHEM DIAGNOSTICS INC.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ARCHITECT — ABBOTT LABORATORIEShsCRP Wide Range Reagent — CLINIQA CORPORATIONK-ASSAY® hs-CRP Control — KAMIYA BIOMEDICAL COMPANY, LLCK-ASSAY® CRP Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCfrCRP — RANDOX LABORATORIES LIMITEDCRP Reagent Kit — MEDICA CORPORATIONPOINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L) — HORIBA INSTRUMENTS INCORPORATEDPulse Scientific Inc. — Pulse Scientific InchsCRP — RANDOX LABORATORIES LIMITEDARCHITECT — ABBOTT LABORATORIESTeco Diagnostics C-Reactive Protein (CRP) Reagent Set — TECO DIAGNOSTICSK-ASSAY® CRP (3) Calibrator F — KAMIYA BIOMEDICAL COMPANY, LLCHIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT — BIOMERICA, INC.K-ASSAY® CRP Calibrator (Ver.2) — KAMIYA BIOMEDICAL COMPANY, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-14 | Ortho-Clinical Diagnostics, Inc. | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. |
| 2024-10-11 | Ortho-Clinical Diagnostics, Inc. | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) wh |
| 2023-02-01 | Randox Laboratories | The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be wit |
| 2016-10-26 | Ortho-Clinical Diagnostics | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2013-05-09 | Ortho-Clinical Diagnostics | While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry |
| 2013-03-06 | Alere San Diego, Inc. | The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause diffe |
| 2009-07-21 | Medtest Holdings, Inc. | Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is |
| 2009-05-01 | Kamiya Biomedical Company, LLC | The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration. |
| 2008-01-10 | Beckman Coulter Inc | IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration. |
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