Gentian AS: Medical Device Recall in 2020 - (Recall #: Z-0099-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: September 2, 2020

Date Posted: October 21, 2020

Recall Number: Z-0099-2021

Event ID: 86465

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.

Status: Terminated

Product Quantity: 107 calibrator kits

Code Information:

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

Distribution Pattern:

US: MN, VA, KS,

Voluntary or Mandated:

Voluntary: Firm initiated