ETEST® Amikacin (AK)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026549923), received between Jul 30, 2020 and Aug 28, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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-0817-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING OUT OF RANGE HIGH RESULTS WHILE TESTING A PSEUDOMONAS AERUGINOSA ATCC® 27853¿ STRAIN USING THE ETEST® STRIP AMIKACIN 256 (REFERENCE # 412218, LOT # 1007980340). ETEST® RESULTS: EXPECTED RANGE: 1-4 ¿G/ML. OBTAINED: 8 ¿G/ML. THE CUSTOMER REPORTED THAT THE STRIP WAS TESTED WITH E. COLI ATCC AND RECEIVED PASSING RESULTS. THERE IS NO PATIENT ASSOCIATED WITH THIS QC ISOLATE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10468878 ↗
• MalfunctionJul 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT OF RANGE HIGH (OOH) RESULTS IN ASSOCIATION WITH THE ETEST® AMIKACIN AK 256 US S30 (REF. 412218, LOT 1007537650) WHEN TESTING ATCC® 27853¿ PSEUDOMONAS AERUGINOSA. THE CUSTOMER TESTED ATCC® 27853¿ PSEUDOMONAS AERUGINOSA MULTIPLE TIMES USING LOT 1007537650 AND MUELLER HINTON AGAR; EACH TEST OBTAINED A MIC VALUE BETWEEN 6-12 ¿G/ML. THE ETEST® AMIKACIN AK 256 US S30 INSTRUCTIONS FOR USE STATE THE EXPECTED RESULT FOR ATCC® 27853¿ PSEUDOMONAS AERUGINOSA IS MIC BETWEEN 1-4 ¿G/ML. THE CUSTOMER CONFIRMED THE ETEST® AMIKACIN AK 256 US S30 STRIPS WERE STORED AT -20°C AND GIVEN FIFTEEN (15) MINUTES TO COME TO ROOM TEMPERATURE PRIOR TO USE. BIOMÉRIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER THAT THE ETEST® AMIKACIN AK 256 US S30 STRIPS INSTRUCTIONS FOR USE (IFU) HANDLING SECTION STATES TO ALLOW THIRTY (30) MINUTES FOR STRIPS HELD AT -20°C TO COME TO ROOM TEMPERATURE PRIOR TO TESTING. THE CUSTOMER PERFORMED QC TESTING FOLLOWING THE ADVICE OF BIOMÉRIEUX CUSTOMER SERVICE; REPEAT TESTING ALSO OBTAINED OUT OF RANGE HIGH RESULTS. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIEN

  Patient problems: No Patient Involvement

  MAUDE report 10345325 ↗