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Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351
Recalled January 24, 2024 · FDA recall Z-0752-2024 · Randox Laboratories
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%. · FDA Class II
Units
269 kits
Sold at
US Nationwide and Puerto Rico.
Description
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%.
Product
Calibration Serum Level 3 CAL2351
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →