Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT
Products Sold
Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product U due to The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The cal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
1. Review your reagent inventory and replace the value sheet with the new values provided. 2. Review results generated with the affected batches in line with the clinical profile of the patient. 3. Discuss the contents of this notice with your Medical Director. 4. Complete and return the response form 12187-QA to teclhnical.services@randox.com within five working days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026