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Lp (a) LP3403Recalls & reported problems

Randox Laboratories Limited · Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K011568); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 20, 2024Open, Classified

    Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

    Z-1017-2025 · Root cause: No Marketing Application · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011568. One submission often covers many models, so check the product and lot details in each record.

  • Z-1018-2025 · Dec 20, 2024 · Open, Classified
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

Other Lipoprotein, Low-Density, Antigen, Antiserum, Control devices

All Lipoprotein, Low-Density, Antigen, Antiserum, Control devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.