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Fluoro-CheckTM AMI 3 in 1
NANO-DITECH CORPORATION · Model TF3154 · UDI-DI 00895160002496
10
510(k) clearances
18,369
Adverse events (13 deaths)
56
Recalls
51
Facilities
Description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma
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) can contaminate an |
| 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 testing won't detect ano |
| 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 inappropriate interventio |
| 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 inappropriate interventio |
| 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 carryover is caused |
| 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 and Elecsys proBNP II/ |
| 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 and Elecsys proBNP II/ |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.