Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GENTIAN Cystatin C Calibrator and Calibrator Kit Recalled by Gentian AS Due to The firm has identified lots of calibrators that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Gentian AS directly.
Affected Products
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)
Quantity: 107 calibrator kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: KS, MN, VA
About Gentian AS
Gentian AS has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report