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)
FDA Recall Z-0099-2021 · Posted None
Recalling FirmGentian AS
Recall StatusTerminated
Product CodeNDY
Date Initiated2020-09-02
Date Terminated2022-09-28
Product Quantity107 calibrator kits
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.
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 confirm that this notification of withdrawal has been received and understood.
Root Cause
Under Investigation by firm
Distribution Pattern
US: MN, VA, KS,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.