FDA Medical Device Recalls (openFDA)
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 distributed in US)
- Recall number
- Z-0099-2021
- 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)
- Status
- Terminated
- Initiated
- 2020-09-02
- Posted
- not on file
- Terminated
- 2022-09-28
- 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 confirm that this notification of withdrawal has been received and understood.
- Quantity
- 107 calibrator kits
- Distribution
- US: MN, VA, KS,
- Lot, serial or model codes
- Lot numbers #s: 1905415,1904404,1904403,1809403
- 510(k) numbers
- ["K071388","K081875"]
- PMA numbers
- not on file
- Product code
- NDY
- Firm FEI
- 3006801241
- Firm city
- Moss
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28