FDA-Device2024-01-24Class II
Calibration Serum Level 3 CAL2351
Randox Laboratories Ltd.
Hazard
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Sold states
US Nationwide and Puerto Rico.
Affected count
269 kits
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Calibration Serum Level 3 CAL2351
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2024Don't want to check this manually?
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