Moss, N/A, Norway
Gentian AS recalls
1 recall recorded since 2018, most recently on 2 September 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 September 2020
- Terminated
- 28 September 2022
- Reason
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0099-2021
- 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:
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.