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Nano-CheckTM hs-CRP
NANO-DITECH CORPORATION · Model CD7152 · UDI-DI 00895160002052
10
510(k) clearances
49
Adverse events
6
Recalls
35
Facilities
Description
In Vitro Diagnostic Test kit for the evaluation of hs-CRP in human whole blood, plasma or serum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-17 | Siemens Healthcare Diagnostics, Inc. | The potential for falsely elevated results. |
| 2025-03-11 | Siemens Healthcare Diagnostics, Inc. | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. |
| 2020-11-06 | Roche Diagnostics Operations, Inc. | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discolor |
| 2019-04-25 | The Binding Site Group, Ltd. | A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected |
| 2019-02-19 | The Binding Site Group, Ltd. | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits |
| 2008-04-15 | Siemens Healthcare Diagnostics, Inc. | falsely elevated results in EDTA plasma samples |
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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.