GENTIAN Cystatin C Calibrator and Calibrator Kit — Class II medical device recall Z-0099-2021
Terminated recall by Gentian AS, reported 2020-10-21, distributed in KS, MN, VA. The firm has identified lots of calibrators that have shown to measure incorrect high values over time compare
| Recall number | Z-0099-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentian AS, Moss, N/A, Norway |
| Recall initiated | 2020-09-02 |
| Classified | 2020-10-13 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2022-09-28 |
| Distributed | KS, MN, VA |
| Quantity | 107 calibrator |
| UPC / GTIN / UDI-DI | 07090038460092, 07090038460108, 17090038460037 |
| Lot numbers | 1809403, 1904403, 1904404, 1905415 |
| Model numbers | 1012, 1051, 8012, A52763 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0099-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.