mALB MA2423
mALB MA2423 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K002674 on 5 Oct 2000 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273204537), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055273204537 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK002674 | Date5 Oct 2000 | StatusActive |
Official records
- AccessGUDID record 05055273204537
- FDA 510(k) database K002674
Across registries
- FDA 510(k) K002674 decided 5 Oct 2000 Active
- FDA GUDID UDI-DI 05055273204537 listed 16 Sep 2016 Listed
Recalls
-
- Ongoing Z-1594-2024
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%.
Timeline
- Cleared FDA 510(k) K002674
- Listed FDA GUDID 05055273204537
- Recall initiated FDA recalls Z-1594-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- mALB
- Generic name
- Microalbumin IVD, kit, nephelometry/turbidimetry
- Model / Ref / Catalog
- MA2423
- Primary DI / UDI-DI
- 05055273204537
- 510(k) Number
- FDA product code
- DDZ
- GMDN term
- Microalbumin IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Microalbumin IVD, kit, nephelometry/turbidimetry.