FDA-Device2024-03-27Class II
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Randox Laboratories Ltd.
Hazard
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Sold states
Domestic: CA, FL, IL, ME, NJ, OH, & OR.
Affected count
1,764 units
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2024Don't want to check this manually?
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