Lower riskMedical device recall · FDA · Published March 1, 2024
Randox Liquid Protein Calibrators Recall: Realignment to ERM-DA470k/IFCC Reference
Randox recalls C3 and Haptoglobin liquid protein calibrators (IT2691) used with IgA/IgG/IgM assays due to realignment to ERM-DA470k/IFCC reference material. No immediate safety risk reported.
“Randox Liquid Protein Calibrators Recall: Realignment to ERM-DA470k/IFCC Reference.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56025-randox-liquid-protein-calibrators-recall-realignment-to-erm-da470k-ifcc. Based on FDA recall #Z-1328-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2024%22&limit=1).
Randox Laboratories Ltd. recalled Liquid Protein Calibrators C3 and Haptoglobin on March 1, 2024, according to the FDA. The firm realigned these calibrators to reference material ERM-DA470k/IFCC.
How to tell if you have it
Brand: Randox
Product: Liquid Protein Calibrators C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a March 5, 2024 recall for Clinical Chemistry Calibration Serum due to an Inorganic Phosphate Bias Issue and an April 5, 2024 recall for Evidence MultiSTAT Software v3.7 over light leak risks. Other recent recalls of similar products include the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (March 18, 2026).
How to tell if you have this one
Check for the catalog number IT2691 on the calibrator packaging. These products were sold with batch numbers ending in 2154IT-2158IT (expiring 03/28/25) or 2112IT-2116IT (expiring 07/28/24).
Brand
Randox
Product
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Status
Verify if your calibrator uses the IT2691 catalog number and matches the batch numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 7 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: CA, FL, IL, ME, NJ, OH, & OR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Illinois, Maine, New Jersey, Ohio, Oregon.
Recall timeline
FDA published this recall 26 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1328-2024 (March 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1328-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.