Home / Recalls / Gentian AS / Z-0099-2021

Z-0099-2021 Class II Terminated

Recalled by Gentian AS — Moss, N/A

Recall Details

Product Type
Devices
Report Date
October 21, 2020
Initiation Date
September 2, 2020
Termination Date
September 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
107 calibrator kits

Product Description

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 Pattern

US: MN, VA, KS,

Code Information

Lot numbers #s: 1905415,1904404,1904403,1809403