Z-0099-2021Class II

GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C...

Name: Z-0099-2021 GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C...
Creator: Gentian AS
Published: 2020-09-02
License: https://open.fda.gov/license/

Gentian AS / initiated 2020-09-02 / Terminated / root cause: manufacturing process

FDA source

Gentian AS began a 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: (01)07090038460092... on 2020-09-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0099-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-02
Posted: 2020-10-13
Terminated: 2022-09-28
Recalling firm: Gentian AS
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)
Product code: NDY Test, Cystatin C
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.
Root cause tag: manufacturing process
FDA 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 confirm that this notification of withdrawal has been received and understood.
Quantity in commerce: 107 calibrator kits
Distribution: US: MN, VA, KS,
Product codes and lots: Lot numbers #s: 1905415,1904404,1904403,1809403

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0099-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0099-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-13

Product code NDY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)