FDA-Device2024-01-24Class II
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Randox Laboratories Ltd.
Hazard
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Sold states
US Nationwide including Puerto Rico.
Affected count
108 kits
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0753-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief