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Gentian Cystatin C Single Use Control High
Gentian AS · Model 1030 · UDI-DI 07090038460122
1
510(k) clearances
21
Adverse events
4
Recalls
24
Facilities
Description
The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-07 | Randox Laboratories Ltd. | Cystatin C Reagent marketed without a 510 (k) |
| 2024-02-14 | Randox Laboratories Ltd. | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods |
| 2020-09-02 | Gentian AS | The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could re |
| 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. |
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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.