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ETEST® Vancomycin (VA) (UDI 03573026550356)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

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.

2 other recalls cover devices cleared under the same FDA submission (K980348); 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. Nov 9, 2022Open, Classified

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

    Z-0831-2023 · Root cause: Storage · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K980348. One submission often covers many models, so check the product and lot details in each record.

  • Z-0860-2023 · Nov 9, 2022 · Open, Classified
    ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
  • Z-1525-2017 · Dec 15, 2016 · Terminated
    ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-nega

Other Manual Antimicrobial Susceptibility Test Systems devices

All Manual Antimicrobial Susceptibility Test Systems devices →

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