Test, Cystatin C
Clinical Chemistry · 21 CFR 862.1225
Recent MDR events
21 adverse event reports on file
- N LATEX CYSTATIN CJun 22, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00019
- TINA-QUANT CYSTATIN C GEN.2Dec 15, 2025MalfunctionRoche Diagnostics1823260-2025-05099
- ATELLICA CH CYSTATIN C_2 (CYSC_2)Sep 18, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2025-00241
- ATELLICA CH CYSTATIN C_2 (CYSC_2)Sep 18, 2025MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2025-00242
- ATELLICA CH CYSTATIN C_2 (CYSC_2)Sep 18, 2025MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2025-00243
- ATELLICA CH CYSTATIN C_2 (CYSC_2)Sep 18, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2025-00246
- ATELLICA CH CYSTATIN C_2 (CYSC_2)Sep 18, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2025-00245
- ATELLICA CH CYSTATIN C_2 (CYSC_2)Sep 18, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2025-00244
- TINA-QUANT CYSTATIN C GEN.2Aug 14, 2025MalfunctionRoche Diagnostics1823260-2025-02483
- TINA-QUANT CYSTATIN C GEN.2Jul 29, 2025MalfunctionRoche Diagnostics1823260-2025-02321
Event type breakdown
Recalls
4 recall events for this product code
- Randox Laboratories Ltd.Open, ClassifiedJul 24, 2024
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.
Cystatin C Reagent marketed without a 510 (k)
Z-2425-2024 · View FDA record ↗ - Randox Laboratories Ltd.Open, ClassifiedMar 22, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Z-1369-2024 · View FDA record ↗ - Gentian ASTerminatedUnknown
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models:
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.
Z-0099-2021 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK Cystatin C; Part Number: 025217
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2099-2018 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Agilent Technologies Inc.
Cedar Creek, TX, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
The Binding Site Group Ltd.
BIRMINGHAM, GB
Abbott Laboratories
Lake Forest, IL, US
Tosoh Aia, Inc.
TOYAMA, JP
Horiba Instruments Incorporated
Canton, MI, US
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Kamiya Biomedical Company Llc
Tukwila, WA, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Abbott Gmbh
Wiesbaden Hesse, DE
The Binding Site
Kings Norton Birmingham, GB
Tosoh Bioscience, Inc.
Grove City, OH, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Diazyme Laboratories, Inc.
POWAY, CA, US
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Gentian As
Moss Ostfold, NO
Diamond Diagnostics Inc.
Budapest, HU
Tosoh Corp.
Chuo-ku Tokyo, JP
Sentinel Ch. Spa
MILANO, IT
510(k) clearances
22 clearances for this product code
- SENTINEL CH. SpAMay 16, 2025
K242585 · Cystatin C
- Siemens Healthcare Diagnostics, Inc.May 25, 2018
K181082 · ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
- Siemens Healthcare Diagnostics Products GmbHMay 12, 2017
K171072 · N Latex Cystatin C; N Protein Standard UY
- Roche Diagnostics Operations (Rdo)Jul 27, 2016
K161817 · Tina-quant Cystatin C Gen.2
- Roche DiagnosticsJul 17, 2014
K141143 · COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
- Diazyme LaboratoriesMar 30, 2012
K111664 · DIAZYME CYSTATIN C POC TEST KIT
- Kamiya Biomedical Co.Sep 28, 2010
K093137 · K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
- Tosoh Bioscience, Inc.Sep 14, 2010
K093960 · ST AIA-PACK CYSTATIN C, MODEL 025217