Home › Device types › MOI
System, Test, Immunological, Antigen, Tumor
FDA product code MOI · Class 2 · Immunology
78
Registered devices
208
Adverse events
18
Recalls
28
510(k) clearances
Devices with this code
Atellica IM BR Calibrator — Siemens Healthcare Diagnostics Inc.Atellica IM CA 15-3 — Siemens Healthcare Diagnostics Inc.Head Holder Flexibility — Noras MRI products GmbHMonobind AccuBind CA 15-3 ELISA Kit - 96 Wells — MONOBIND, INC.ADVIA Centaur® BR +G — Siemens Healthcare Diagnostics Inc.Skull Pin with big tip — Noras MRI products GmbHCA 15-3 AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Back Cushion Flexibility Maquet — Noras MRI products GmbHMulti-purpose Screw — Noras MRI products GmbHARCHITECT — Abbott GmbHARCHITECT — ABBOTT LABORATORIESAlinity — Abbott GmbHAtellica IM BR — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems, ACS:180® Systems CA 15-3® Calibrator — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge CA15-3 — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESElecsys CA 153 II Assay — Roche Diagnostics GmbHAtellica IM CA 15-3 — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESElecsys CA 153 II CalSet — Roche Diagnostics GmbHRod long — Noras MRI products GmbHElecsys CA 15-3 II — Roche Diagnostics GmbHBore Gauge Alpha Maquet Plus US — Noras MRI products GmbHAlinity — Abbott GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-18 | Siemens 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 |
| 2021-07-06 | Siemens Healthcare Diagnostics, Inc | Product 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 |
| 2021-07-06 | Siemens Healthcare Diagnostics, Inc | Product 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 |
| 2021-07-06 | Siemens Healthcare Diagnostics, Inc | Product 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 |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2018-01-02 | Siemens 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 |
| 2018-01-02 | Siemens 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 |
| 2017-04-13 | Beckman 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 |
| 2017-03-08 | Siemens Healthcare Diagnostics, Inc | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems |
| 2017-03-08 | Siemens Healthcare Diagnostics, Inc | Potential 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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