ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026549077), received between May 29, 2020 and May 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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.

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 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A POTENTIAL FALSE RESISTANT SXT (TRIMETHOPRIM/SULFAMETHOXAZOLE) RESULT IN ASSOCIATION WITH ETEST® TRIM/SULFA1/19 TS US F 100 TEST STRIPS (REF. 524458, LOT 1007246260) WHEN TESTING A PATIENT STAPHYLOCOCCUS HOMINIS ISOLATE. THE CUSTOMER TESTED THE STAPHYLOCOCCUS HOMINIS ISOLATE USING THE VITEK® 2 AST-GP75 TEST KIT AND ETEST® TRIM/SULFA 1/19 TS US F 100 TEST STRIPS. THE FOLLOWING RESULTS WERE OBTAINED: VITEK® 2 AST-GP75 (INITIAL): SXT TERMINATED DUE TO "INSUFFICIENT GROWTH IN POSITIVE CONTROL WELL". VITEK® 2 AST-GP75 (REPEAT): MIC=40, SUSCEPTIBLE. ETEST®: MIC=>8, RESISTANT. BIOMÉRIEUX COMPLETED AN INTERNAL INVESTIGATION REGARDING THE SUSCEPTIBLE VITEK® 2 RESULTS. THE STAPHYLOCOCCUS HOMINIS STRAIN WAS SUBMITTED AND TESTED USING THE BROTH MICRO DILUTION TEST METHOD, AND OBTAINED A SUSCEPTIBLE RESULT. THIS RESULT INDICATED THE VITEK® 2 AST-GP75 TEST KIT PERFORMED AS INTENDED. THE CUSTOMER STATED THE ETEST® RESULT OF RESISTANT WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10101988 ↗