Randox Laboratories Ltd.: The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

Agency Publication Date: November 4, 2019

Affected Products

Product: Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syp

Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF

Lot Numbers:

463479

Product: Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimensi

Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT

Lot Numbers:

440973

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83791

Status: Resolved

Manufacturer: Randox Laboratories Ltd.

Manufactured In: Ireland

Units Affected: 2 products (17 kits; 100 kits)

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Sources: FDA iRES · Raw API Response

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Affected Products

Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF

Lot Numbers:

463479

Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT

Lot Numbers:

440973