FDA Device recall 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:…
- FDA Device
- Class II
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of 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:… by Gentian As, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0099-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-02 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Gentian As |
| Distribution | KS, MN, VA |
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.
Identifiers
| code_info | Lot numbers #s: 1905415,1904404,1904403,1809403 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0099-2021%22
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