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LIPASE (LPS) LI3837Recalls & reported problems

Randox Laboratories Limited · A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma · Class 1

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.

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. Jun 26, 2020Terminated

    Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.

    Z-2751-2020 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Other Lipase-Esterase, Enzymatic, Photometric, Lipase devices

All Lipase-Esterase, Enzymatic, Photometric, Lipase devices →

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