Home › Device types › MMI
Immunoassay Method, Troponin Subunit
FDA product code MMI · Class 2 · Clinical Chemistry
113
Registered devices
18,095
Adverse events
56
Recalls
95
510(k) clearances
Devices with this code
ADVIA Centaur® TnI-Ultra™ — Siemens Healthcare Diagnostics Inc.StatusFirst™ Tn I card — PRINCETON BIOMEDITECH CORPORATIONTROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT — BIOMERICA, INC.Cardiac STATus® TnI — International Point of Care IncorporatedNano-CheckTM 4 in 1 Test — NANO-DITECH CORPORATIONi-STAT — ABBOTT POINT OF CARE INC.IMMULITE®/IMMULITE® 1000 Systems TPI Troponin I Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Troponin I STAT Immunoassay — Roche Diagnostics GmbHPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDDimension Vista®/Dimension® EXL™ CTNI SDIL — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ cTNI TestPak — Siemens Healthcare Diagnostics Inc.Triage — QUIDEL CARDIOVASCULAR INC.Atellica IM TNIH — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ cTNI DilPak — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT IRELANDAccess AccuTnI+3 — Beckman Coulter, Inc.ARCHITECT — ABBOTT IRELANDTriage — QUIDEL CARDIOVASCULAR INC.IMMULITE® 1000 Systems TPI Troponin I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Troponin T Gen 5 — Roche Diagnostics GmbHAtellica IM TNIH — Siemens Healthcare Diagnostics Inc.ADVIA Centaur TNIH 500T Kit — Siemens Healthcare Diagnostics Inc.Elecsys Troponin I Immunoassay — Roche Diagnostics GmbHi-STAT hs-TnI cartridge — Abbott Point of Care Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-18 | Beckman Coulter, Inc. | Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) |
| 2023-06-05 | ORTHO-CLINICAL DIAGNOSTICS | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| 2023-06-05 | ORTHO-CLINICAL DIAGNOSTICS | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| 2023-05-25 | QUIDEL CARDIOVASCULAR INC | Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC test |
| 2022-07-26 | Abbott Laboratories | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. |
| 2022-05-18 | Siemens Healthcare Diagnostics, Inc. | Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inapp |
| 2022-05-18 | Siemens Healthcare Diagnostics, Inc. | Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inapp |
| 2021-08-09 | Beckman Coulter Inc. | Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The |
| 2021-04-07 | Roche Diagnostics Operations, Inc. | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT an |
| 2021-04-07 | Roche Diagnostics Operations, Inc. | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT an |
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