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Lp (a)Recalls & reported problems across all models

Randox Laboratories Limited · 2 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name at least one Lp (a) model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
2

We found 2 models of Lp (a) by Randox Laboratories Limited in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Lp (a) recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Dec 20, 2024Open, Classified

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

    Z-1018-2025 · Root cause: No Marketing Application · Recall details · FDA record ↗

  2. 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 · Recall details · FDA record ↗

Lp (a) models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Randox Laboratories Limited products

All Randox Laboratories Limited devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page