Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1369-2024 — Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

U.S. FDA — Device Enforcement · Ireland · 2024-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1369-2024
Date of alert
2024-02-14
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273207439
Reported risk: Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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