Lower riskMedical device recall · FDA · Published January 31, 2024
Randox Microalbumin Calibrator Series May Misclassify Patient Results
Randox recalls Microalbumin Calibrator Series (mAL:CAL) MA1567 and MA2426 due to potential misclassification of patient results. Users may see up to +12% shifts in quality control and sample recovery.
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
“Randox Microalbumin Calibrator Series May Misclassify Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56210-randox-microalbumin-calibrator-series-may-misclassify-patient-results. Based on FDA recall #Z-1593-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1593-2024%22&limit=1).
The FDA announced on Jan. 31, 2024, that Randox Laboratories Ltd. is recalling Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number MA1567. The agency said the product may misclassify patient results due to a negative bias.
How to tell if you have it
Brand: Randox
Product: Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay
Catalog Number: MA1567
GTIN: 05055273204520
Lot codes: 619282 / 1094MA-1098MA
Quantity: 8 units
Distribution: US Nationwide, including GA, MA, WV and PR
The hazard
GovInfoNow's records show the Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods. This may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Other recent recalls include the Randox Cystatin C Reagent Recall (2024-06-07), the Randox Evidence MultiSTAT Software v3.7 Recall (2024-04-05), and the Randox Clinical Chemistry Calibration Serum Recall (2024-03-05). Other recent recalls of similar products include the Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16) and the Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (2025-12-11).
How to tell if you have this one
Check for the product name 'Microalbumin Calibrator Series (mALB CAL)' with catalog numbers MA1567 or MA2426. The batch numbers are 619282 or 1094MA-1098MA.
Brand
Randox
Product
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of GA, MA, WV including PR.
Recall number
Product, codes & lots
Quantity
Z-1593-2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567; GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
8 units
Z-1594-2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426; GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA
6 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the catalog number (MA1567 or MA2426) and batch number (619282 or 1094MA-1098MA) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, MA, WV including PR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Massachusetts, Puerto Rico, West Virginia.
Recall timeline
FDA published this recall 3 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 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-1593-2024 (January 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1593-2024 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.