Recall Z-0099-2021 ยท NDY Test, Cystatin C
Gentian AS
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
| Date | Sep 2, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Gentian AS issued a "Field Safety Notice" letter on September 2, 2020 concerning the removal of the Gentian Cystatin C Calibrator and Calibrator Kit. In addition, to informing consignees about the recall the firm asked consignees to take the following actions: 1. Discontinue use of the affected lots listed in this Field Safety Notice 2. Please inform Gentian of remaining stock of the affected lots numbers given in this Field Safety Notice. 3. Share this notification with other relevant personnel in your organization and affected customers 4. Please sign and return this document by e-mail to |
| Quantity | 107 calibrator kits |
| Distribution | US: MN, VA, KS, |
| FDA record | Open on fda.gov |