Randox recalls Calibration Serum Level 3 CAL2351 (lot numbers 1214UE-1315UE) due to potential 13% shift in test accuracy on RX Series instruments. Affected users should contact Randox for guidance.
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
“Randox Calibration Serum Level 3 CAL2351 recall: 13% test accuracy shift risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56798-randox-calibration-serum-level-3-cal2351-recall-13-test-accuracy. Based on FDA recall #Z-0752-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2024%22&limit=1).
The FDA announced on November 20, 2023, that Randox Laboratories Ltd. is recalling Calibration Serum Level 3 CAL2351 due to a positive bias in CK Total readings. This defect can cause shifts in quality control and patient sample recovery of up to 13% on RX Series instruments.
How to tell if you have it
Brand: Randox
Product: Calibration Serum Level 3 CAL2351
UPC: 05055273200966
Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
The hazard
According to the FDA, CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments. This issue may cause a shift in Quality Control and patient sample recovery of up to 13% compared to other methods.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent similar recalls include the Randox Clinical Chemistry Calibration Serum Recall dated March 5, 2024, which involved an inorganic phosphate bias issue, and the Randox Cystatin C Reagent Recall dated June 7, 2024, for missing FDA 510(k) clearance. Other recent recalls of similar products include the Siemens Healthcare Syva Emit Tox Serum Calibrators Recall (June 26, 2026), the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), and the Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).
How to tell if you have this one
Check for lot numbers 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, or 1315UE on the product label. The product is sold under the brand Randox Laboratories Ltd.
Brand
Randox
Product
Calibration Serum Level 3 CAL2351
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Randox
Reach out to Randox Laboratories Ltd. for specific guidance on handling the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months 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 recall indicates a potential 13% shift in test accuracy, but it does not pose a direct safety risk like injury or fire. The hazard is related to test accuracy, not physical harm.
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-0752-2024 (November 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0752-2024 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.