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 is recalling cystatin C calibrators that may measure higher than assigned values over time. This could lead to inaccurate patient test results if used in medical settings.
The calibrators may show higher Cystatin C values than intended over time. This could lead to inaccurate patient test results if the device is used in medical settings.
Healthcare professionals using the calibrators for patient testing are most at risk. The recall affects specific models sold with reference numbers listed in the notice.
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.
Look for reference numbers like REF 1012 or UDI codes listed in the recall notice to identify affected models.
The firm identified calibrators that measure incorrect high values over time compared to assigned values, which could lead to inaccurate patient test results.
Affected models include Gentian C E, Cystatin C Calibrator (1 x 1 mL, REF 1012), Calibrator Kit (6 x 1 mL, REF 1051), and specific lot numbers listed in the recall notice.
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.
We’ve drafted a message you can send Gentian to request your refund or repair — edit it as you like.
Subject: Recall Z-0099-2021 — Gentian Gentian Hello, I own a Gentian that is covered by recall Z-0099-2021 from Gentian. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
