ETEST® Ceftazidime (TZ)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026550066), received between Mar 24, 2021 and Jan 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K971694); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT CEFTAZIDIME RESULTS FOR PSEUDOMONAS STUTZERI IN ASSOCIATION WITH CEFTAZIDIME TZ 256 US S30 (REF. 412292, LOT 1007980190, EXP DATE 3/30/2022). THE CUSTOMER STATED THEY HAD A VITEK® 2 / ETEST® DISCREPANCY FOR PSEUDO. STUTZERI FOR CEFTAZIDIME. THE CUSTOMER STATED THAT VITEK 2 REPORTED CEFTAZIDIME AS SUSCEPTIBLE, BUT CEFTAZIDIME ETEST® REPORTED AS RESISTANT. SUMMARY: PATIENT STRAIN PSEUDOMONAS STUTZERI FROM A WOUND SAMPLE. VITEK 2 RESULT: CEFTAZIDIME MIC=1, S. ETEST RESULT: CEFTAZIDIME MIC=256, R. THERE IS NO EVIDENCE OF OFF-LABEL USE BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156730 ↗
• MalfunctionMar 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "EVALUATION OF THE PERFORMANCE OF MANUAL ANTIMICROBIAL SUSCEPTIBILITY TESTING METHODS AND DISK BREAKPOINTS FOR STENOTROPHOMONAS MALTOPHILIA" BY KHAN, A. ET AL. THIS SCIENTIFIC ARTICLE HIGHLIGHTED DISCREPANT RESULTS USING ETEST® CEFTAZIDIME TZ 256 US S30 (REF. 412292). THE BATCH NUMBERS USED FOR THE STUDY ARE UNKNOWN. THE AUTHORS COMPARED REFERENCE METHOD, BROTH MICRODILUTION TO OTHER METHODS, INCLUDING ETEST® , IN ORDER TO EVALUATE THE MIC OF 109 STRAINS OF STENOTROPHOMONAS MALTOPHILA. THE SAMPLES WERE COLLECTED FROM CLINICAL BLOOD CULTURES COLLECTED FROM 2015 TO 2019. THE ANTIBIOTICS TESTED WERE TRIMETHOPRIM/SULFAMETHOXAZOLE, LEVOFLOXACIN, MINOCYCLINE, CEFTAZIDIME, CIPROFLOXACIN AND TIGECYCLINE. IT SHOULD BE NOTED THAT THERE ARE NO CURRENT APPROVED BREAK POINTS APPROVED BY THE FDA FOR STENOTROPHOMONAS MALTOPHILA. PER THE PUBLICATION " IN 2009, THE FDA DISCONTINUED THE CLEARANCE OF ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) DEVICES USING CLSI BREAKPOINTS. AS THERE ARE NO FDA-RECOGNIZED S. MALTOPHILIA BREAKPOINTS, FDA CLEARANCE OF COMMERCIAL AST DEVICES FOR THIS ORGANISM IS NO LONGER PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563656 ↗
• MalfunctionMar 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "EVALUATION OF THE PERFORMANCE OF MANUAL ANTIMICROBIAL SUSCEPTIBILITY TESTING METHODS AND DISK BREAKPOINTS FOR STENOTROPHOMONAS MALTOPHILIA" BY KHAN, A. ET AL. THIS SCIENTIFIC ARTICLE HIGHLIGHTED DISCREPANT RESULTS USING ETEST® CEFTAZIDIME TZ 256 US S30 (REF. 412292). THE BATCH NUMBERS USED FOR THE STUDY ARE UNKNOWN. THE AUTHORS COMPARED REFERENCE METHOD, BROTH MICRODILUTION TO OTHER METHODS, INCLUDING ETEST® , IN ORDER TO EVALUATE THE MIC OF 109 STRAINS OF STENOTROPHOMONAS MALTOPHILA. THE SAMPLES WERE COLLECTED FROM CLINICAL BLOOD CULTURES COLLECTED FROM 2015 TO 2019. THE ANTIBIOTICS TESTED WERE TRIMETHOPRIM/SULFAMETHOXAZOLE, LEVOFLOXACIN, MINOCYCLINE, CEFTAZIDIME, CIPROFLOXACIN AND TIGECYCLINE. IT SHOULD BE NOTED THAT THERE ARE NO CURRENT APPROVED BREAK POINTS APPROVED BY THE FDA FOR STENOTROPHOMONAS MALTOPHILA. PER THE PUBLICATION " IN 2009, THE FDA DISCONTINUED THE CLEARANCE OF ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) DEVICES USING CLSI BREAKPOINTS. AS THERE ARE NO FDA-RECOGNIZED S. MALTOPHILIA BREAKPOINTS, FDA CLEARANCE OF COMMERCIAL AST DEVICES FOR THIS ORGANISM IS NO LONGER PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K971694. One submission often covers many models, so check the product and lot details in each record.

• Z-1521-2017 · Dec 15, 2016 · Terminated
  ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-neg