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Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical c

Recalled January 11, 2023 · FDA recall Z-0904-2023 · Randox Laboratories

Hazard
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range · FDA Class II
Units
115 units
Sold at
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.

Description

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Product
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical c | RecallWatchUSA