# FDA recall Z-0099-2021

> **Gentian AS** · Class II · device recall initiated 2020-09-02.

## 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)

## Reason for recall

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.

## Distribution

US: MN,  VA, KS,

## Key facts

- **Recall number:** Z-0099-2021
- **Recalling firm:** Gentian AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-02
- **Report date:** 2020-10-21
- **Termination date:** 2022-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Moss, N/A, Norway

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2021

## Citation

> AI Analytics. FDA recall Z-0099-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0099-2021. Source: US FDA. Licensed CC0.

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