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Randox Laboratories recalls CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cat
Recalled April 5, 2023 · FDA recall Z-1286-2023 · Randox Laboratories
Hazard
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range · FDA Class II
Units
2 kits
Sold at
PA, OH, WV
Description
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Product
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Manufacturer(s)
Randox Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →