Randox Liquid Protein Calibrators Recall: Ferritin Results May Be 10% Higher
Randox recalls specific batches of liquid protein calibrators due to potential 10% higher ferritin results. Affected batches include 627222, 627224, 634886, and 634887. No action is required for users.
Lower-risk recall
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
Contact the company
What happened, in plain English
Randox is recalling specific batches of liquid protein calibrators that may cause ferritin test results to be 10% higher than expected. This could lead to inaccurate medical diagnoses if used in patient testing. The recall does not require immediate action for users. Read more at govinfonow.com/recall/57626-randox-liquid-protein-calibrators-recall-ferritin-results-may-be-10.
Source Summary by GovInfoNow · govinfonow.com/recall/57626-randox-liquid-protein-calibrators-recall-ferritin-results-may-be-10 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2448-2023
Cite this page
“Randox Liquid Protein Calibrators Recall: Ferritin Results May Be 10% Higher.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57626-randox-liquid-protein-calibrators-recall-ferritin-results-may-be-10. Based on FDA recall #Z-2448-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2448-2023%22&limit=1).
Why it’s dangerous
The recalibrated calibrators may produce ferritin results that are 10% higher than intended. This could cause inaccurate test results for certain blood tests, potentially affecting medical diagnoses. However, the issue does not pose a direct safety risk to users.
Who’s affected
Users of Randox Liquid Protein Calibrators-SP CAL-(LIQ) for medical testing are affected. Laboratories using the recalled batches (627222, 627224, 634886, 634887) are most at risk.
How to tell if you have this one
Check for batch numbers 627222, 627224, 634886, or 634887 on the calibrator packaging. The product is used for calibrating blood tests for ferritin and other markers.
- Brand
Randox- Product
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement- Category
Medical device
What to do — step by step
Check Batch Number
Look for batch numbers 627222, 627224, 634886, or 634887 on the calibrator packaging.
Where it went and when
Where it was distributed
Distributed in 9 states.
FDA distribution: “CA, FL, IL, ME, MI, NC, OH, PA,NJ,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Illinois, Maine, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to do anything with these calibrators?
No action is required. The recall does not affect the safety of the product but may impact test accuracy.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-2448-2023 (July 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2448-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.