ETEST® Tobramycin (TM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026550301), received between May 21, 2021 and May 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K102668); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0830-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2021Low Test Results; Low Test Results

  INTENDED USE: ETEST® IS A QUANTITATIVE TECHNIQUE FOR DETERMINING THE ANTIMICROBIAL SUSCEPTIBILITY OF GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA SUCH AS ENTEROBACTERIACAEA, PSEUDOMONAS, STAPHYLOCOCCUS AND ENTEROCOCCUS SPECIES AND FASTIDIOUS BACTERIA, SUCH AS ANAEROBES, N. GONORRHOEAE, S. PNEUMONIAE, STEPTOCOCCUS AND HAEMOPHILUS SPECIES. THE SYSTEM COMPRISES A PREDEFINED ANTIBIOTIC GRADIENT WHICH IS USED TO DETERMINE THE MINIMUM INHIBITORY CONCENTRATION (MIC), IN ¿G/ML, OF DIFFERENT ANTIMICROBIAL AGENTS AGAINST MICROORGANISMS AS TESTED ON AGAR MEDIUM USING OVERNIGHT INCUBATION. DESCRIPTION OF THE ISSUE: A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING OUT-OF-RANGE-LOW RESULTS ON QUALITY STRAIN ENTEROCOCCUS FAECALIS ATCC® 29212¿ WHEN USING THE ETEST® TOBRAMYCIN TM 256 US S30 - REFERENCE 412478 - LOT #1007859110 - EXPIRATION DATE: 30/01/2022. THE CUSTOMER OBTAINED TOBRAMYCIN MIC = 4 UG/ML WHILE THE EXPECTED RANGE FOR THIS QC STRAIN IS FROM 8 UG/ML TO 32UG/ML. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102668. One submission often covers many models, so check the product and lot details in each record.

• Z-1531-2017 · Dec 15, 2016 · Terminated
  ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-