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Nano-CheckTM 4 in 1 Test
NANO-DITECH CORPORATION · Model CD402P · UDI-DI 00895160002458
10
510(k) clearances
86
Adverse events (1 deaths)
12
Recalls
45
Facilities
Description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-21 | Abbott Laboratories | The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect m |
| 2019-07-02 | Roche Diagnostics Operations, Inc. | The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay |
| 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, depending upon the assay. |
| 2016-08-08 | Siemens Healthcare Diagnostics, Inc | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2009-01-19 | Abbott Laboratories | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| 2007-09-27 | Beckman Coulter Inc | Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices proto |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent k |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Te |
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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.