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Gentian AS

1 recall •
🏥 Medical Devices
• Categories: Other Medical Devices

GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)

Class I - Dangerous

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 result in higher Cystatin C values measured in patients.

Sep 2, 2020 Other Medical Devices View Details →