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Gentian AS recalls GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1
Recalled October 21, 2020 · FDA recall Z-0099-2021 · Gentian AS
Hazard
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. · FDA Class II
Units
107 calibrator kits
Sold at
US: MN, VA, KS,
Description
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.
Product
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)
Manufacturer(s)
Gentian AS
Made in
Norway
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →