FDA-Device2024-05-15Class II
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Randox Laboratories Ltd.
Hazard
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.
Sold states
Domestic: Nationwide Distribution.
Affected count
80,366 units (US: 242 units; OUS: 80,094 units)
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1759-2024Don't want to check this manually?
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