Lower riskMedical device recall · FDA · Published September 2, 2020
Gentian Cystatin C Calibrator Recall: Incorrect High Measurements Risk
Gentian recalls cystatin C calibrators that may measure higher than assigned values over time, potentially leading to inaccurate patient results. Affected models include Gentian C E calibrators with specific reference numbers.
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.
“Gentian Cystatin C Calibrator Recall: Incorrect High Measurements Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64383-gentian-cystatin-c-calibrator-recall-incorrect-high-measurements-risk. Based on FDA recall #Z-0099-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0099-2021%22&limit=1).
The FDA announced on September 2, 2020, that Gentian AS is recalling GENTIAN Cystatin C Calibrator and Calibrator Kit due to a hazard. The calibrators may measure incorrect high values over time compared to assigned values. This could result in higher Cystatin C values measured in patients.
How to tell if you have it
Gentian C E, Cystatin C Calibrator, REF 1012, UPC 07090038460092
Gentian C E Calibrator Kit, REF 1051, UPC 07090038460108
Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, REF 1051, UPC 17090038460037
Gentian C E, Cystatin C Calibrator, REF 8012
Lot numbers: 1905415, 1904404, 1904403, 1809403
The hazard
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.
Context
GovInfoNow's records show other recent recalls of similar products include Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18), Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13).
How to tell if you have this one
Check for the model numbers: Gentian C E, Cystatin C Calibrator (1 x 1 mL), REF 1012, or other specific reference numbers listed in the recall notice.
Brand
Gentian
Product
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for reference numbers like REF 1012 or UDI codes listed in the recall notice to identify affected models.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “US: MN, VA, KS,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kansas, Minnesota, Virginia.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall does not require immediate stop use; affected users should check product details and follow the provided steps to identify and handle affected items.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0099-2021 (September 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0099-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.