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VIDAS® LH 30406-01Recalls & reported problems

Biomerieux SA · VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of LH concentration in human serum or plasma . · Class 1

2 open recalls name 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
2

Summary

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

2 FDA recall records name this device's 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, 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. Nov 9, 2022Open, Classified

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    Z-0865-2023 · Root cause: Storage · FDA record ↗

  2. Sep 22, 2021Open, Classified

    bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

    Z-0433-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Other RADIOIMMUNOASSAY, LUTEINIZING HORMONE devices

All RADIOIMMUNOASSAY, LUTEINIZING HORMONE devices →

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