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

Recall Z-1759-2024 — Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

U.S. FDA — Device Enforcement · Ireland · 2024-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1759-2024
Date of alert
2024-03-05
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273200966
Reported risk: Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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