Microalbumin Calibrator Series — Class II medical device recall Z-1594-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-04-24, distributed nationwide. Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may
| Recall number | Z-1594-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2024-01-31 |
| Classified | 2024-04-17 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 05055273204544 |
| Lot numbers | 1083MA, 1083MA-1087MA, 1087MA, 1108MA-1112MA, 602114, 636645, 662429 |
| Model numbers | MA2426 |
Product
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Reason for recall
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1594-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.