Recall Z-0099-2021— Gentian AS

Name: FDA recall Z-0099-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

Class II · Terminated

Class II FDA medical device recall by Gentian AS, initiated 2020-09-02, terminated 2022-09-28. It names 2 FDA 510(k) clearances: K081875, K071388. 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: 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..

Recalling firm: Gentian AS
Classification: Class II
Status: Terminated
Initiated: 2020-09-02
Terminated: 2022-09-28
Firm location: Moss, N/A, Norway

510(k) clearances named in this recall

2 on FDA's record

K081875 — GENTIAN CYSTATIN C IMMUNOASSAYGentian AS·cleared 2008-08-20
K071388 — GENTIAN CYSTATIN C IMMUNOASSAYGentian AS·cleared 2007-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.