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System, Test, Immunological, Antigen, Tumor

FDA product code MOI · Class 2 · Immunology

78
Registered devices
210
Adverse events
18
Recalls
28
510(k) clearances

Devices with this code

Alinity — Abbott GmbHAtellica IM BR — Siemens Healthcare Diagnostics Inc.Clamp toothed — Noras MRI products GmbHAIA-PACK 27.29 Sample Diluting Solution — TOSOH CORPORATIONAtellica IM CA 15-3 — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems, ACS:180® Systems CA 15-3® Calibrator — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHADVIA Centaur® BR Pre — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CA 15-3® — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® BR MCM — Siemens Healthcare Diagnostics Inc.CA 15-3 AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Bore Gauge TruSystem 7500 US — Noras MRI products GmbHST AIA-PACK 27.29 — TOSOH CORPORATIONCoil Fixation Block — Noras MRI products GmbHAtellica IM BR PRE — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESIMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCentral Nut — Noras MRI products GmbHAtellica IM BR — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge CA15-3 — Siemens Healthcare Diagnostics Inc.Rod long — Noras MRI products GmbHLocking Screw — Noras MRI products GmbHLeyla Disc — Noras MRI products GmbHAtellica IM CA 15-3® Calibrator — Siemens Healthcare Diagnostics Inc.

Recent recalls

DateFirmReason
2022-07-18Siemens Healthcare Diagnostics, Inc.Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisio
2021-07-06Siemens Healthcare Diagnostics, IncProduct does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for a
2021-07-06Siemens Healthcare Diagnostics, IncProduct does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for a
2021-07-06Siemens Healthcare Diagnostics, IncProduct does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for a
2018-03-05Tosoh Bioscience IncAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin
2018-01-02Siemens Healthcare Diagnostics, Inc.Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista
2018-01-02Siemens Healthcare Diagnostics, Inc.Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista
2017-04-13Beckman Coulter Inc.Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Compete
2017-03-08Siemens Healthcare Diagnostics, IncPotential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
2017-03-08Siemens Healthcare Diagnostics, IncPotential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.