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ETEST® Levofloxacin (LE)Recalls & reported problems

Biomerieux SA · Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Nov 9, 2022Class IIOpen, Classified

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

    Z-0826-2023 · Root cause: Storage · Recall details · FDA record ↗

Other Manual Antimicrobial Susceptibility Test Systems devices

All Manual Antimicrobial Susceptibility Test Systems devices →

Sources and updates

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