Randox Calibration Serum Level 3 Recall: Misassigned ALP Target Causes Errors
Randox recalls Calibration Serum Level 3 (CAL2351) due to misassigned Alkaline Phosphatase target causing inaccurate test results. Affected units may have errors in clinical chemistry assays.
Lower-risk recall
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
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What happened, in plain English
Randox is recalling Calibration Serum Level 3 (CAL2351) because it has a misassigned Alkaline Phosphatase target that can cause inaccurate test results in clinical chemistry assays. This affects the reliability of patient and quality control samples when used with RX Series instruments. Read more at govinfonow.com/recall/56791-randox-calibration-serum-level-3-recall-misassigned-alp-target-causes.
Source Summary by GovInfoNow · govinfonow.com/recall/56791-randox-calibration-serum-level-3-recall-misassigned-alp-target-causes · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0753-2024
Cite this page
“Randox Calibration Serum Level 3 Recall: Misassigned ALP Target Causes Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56791-randox-calibration-serum-level-3-recall-misassigned-alp-target-causes. Based on FDA recall #Z-0753-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2024%22&limit=1).
Why it’s dangerous
The serum's Alkaline Phosphatase target is misassigned by about 10% for RX Series instruments. This can lead to inaccurate test results for patient samples and quality control checks in clinical chemistry assays.
Who’s affected
Healthcare professionals using the Calibration Serum Level 3 for clinical chemistry assays with RX Series instruments are affected. Patients receiving tests using this serum may have inaccurate results.
How to tell if you have this one
Check for the catalog number CAL2351 on the serum label. The lot/batch number is 1214UE with an expiration date of November 28, 2023.
- Brand
Randox- Product
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number CAL2351 and lot/batch number 1214UE on the serum label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide including 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.
- 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
Is this serum safe to use?
The recall indicates potential inaccuracies in test results, but the serum itself is not unsafe. Users should check the recall details before use.
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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-0753-2024 (November 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0753-2024 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.