Home › Siemens Healthcare Diagnostics Inc. › Dimension EXL LOCI Troponin I High Sensitive
Dimension EXL LOCI Troponin I High Sensitive
Siemens Healthcare Diagnostics Inc. · Model 10471068 · UDI-DI 00842768037726
1
510(k) clearances
18,095
Adverse events (13 deaths)
56
Recalls
51
Facilities
Description
LOCI High-Sensitivity Troponin I (TNIH)
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.