ETEST® Daptomycin (DPC)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03573026550547), received between Oct 25, 2023 and Nov 2, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023High Test Results; High Test Results

  PRODUCT DESCRIPTION: ETEST® IS A MANUAL, QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY OF NON-FASTIDIOUS GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA AND FASTIDIOUS BACTERIA. 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 TESTED ON AGAR MEDIA AFTER OVERNIGHT INCUBATION. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED INCORRECT ANTIBIOTIC SUSCEPTIBILITY TEST RESULTS WHEN TESTING FIVE PATIENTS' SAMPLES' USING ETEST TECHNIQUE. THE CUSTOMER SAID THAT THEY HAD TESTED VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) ISOLATED FROM 5 DIFFERENT PATIENTS' SAMPLES' USING ETEST DAPTOMYCIN DPC 256 US S30 - REFERENCE (B)(4) (LOT#1010146860 - EXPIRATION DATE : 19/07/2025) IN ASSOCIATION WITH MUELLER HINTON PLATES AND THAT THEY HAD OBTAINED DAPTOMYCIN RESISTANT RESULTS. THE CUSTOMER REPORTED THAT THEY HAD NOTICED INCONSISTENT RESULTS WITH DAPTOMYCIN ETEST WHEN USING MUELLER HINTON SMALL PLATES COMPARED WITH MUELLER HINTON LARGE PLATES. LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE CU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055344 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  PRODUCT DESCRIPTION: ETEST® IS A MANUAL, QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY OF NON-FASTIDIOUS GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA AND FASTIDIOUS BACTERIA. 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 TESTED ON AGAR MEDIA AFTER OVERNIGHT INCUBATION. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED INCORRECT ANTIBIOTIC SUSCEPTIBILITY TEST RESULTS WHEN TESTING FIVE PATIENTS' SAMPLES' USING ETEST TECHNIQUE. THE CUSTOMER SAID THAT THEY HAD TESTED VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) ISOLATED FROM 5 DIFFERENT PATIENTS' SAMPLES' USING ETEST DAPTOMYCIN DPC 256 US S30 - REFERENCE (B)(4)(LOT#1010146860 - EXPIRATION DATE : 19/07/2025) IN ASSOCIATION WITH MUELLER HINTON PLATES AND THAT THEY HAD OBTAINED DAPTOMYCIN RESISTANT RESULTS. THE CUSTOMER REPORTED THAT THEY HAD NOTICED INCONSISTENT RESULTS WITH DAPTOMYCIN ETEST WHEN USING MUELLER HINTON SMALL PLATES COMPARED WITH MUELLER HINTON LARGE PLATES. LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE CUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055285 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  PRODUCT DESCRIPTION: ETEST® IS A MANUAL, QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY OF NON-FASTIDIOUS GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA AND FASTIDIOUS BACTERIA. 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 TESTED ON AGAR MEDIA AFTER OVERNIGHT INCUBATION. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED INCORRECT ANTIBIOTIC SUSCEPTIBILITY TEST RESULTS WHEN TESTING FIVE PATIENTS' SAMPLES' USING ETEST TECHNIQUE. THE CUSTOMER SAID THAT THEY HAD TESTED VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) ISOLATED FROM 5 DIFFERENT PATIENTS' SAMPLES' USING ETEST DAPTOMYCIN DPC 256 US S30 - REFERENCE (B)(4) (LOT#1010146860 - EXPIRATION DATE : 19/07/2025) IN ASSOCIATION WITH MUELLER HINTON PLATES AND THAT THEY HAD OBTAINED DAPTOMYCIN RESISTANT RESULTS. THE CUSTOMER REPORTED THAT THEY HAD NOTICED INCONSISTENT RESULTS WITH DAPTOMYCIN ETEST WHEN USING MUELLER HINTON SMALL PLATES COMPARED WITH MUELLER HINTON LARGE PLATES. LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE CUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055284 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  PRODUCT DESCRIPTION: ETEST® IS A MANUAL, QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY OF NON-FASTIDIOUS GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA AND FASTIDIOUS BACTERIA. 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 TESTED ON AGAR MEDIA AFTER OVERNIGHT INCUBATION. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED INCORRECT ANTIBIOTIC SUSCEPTIBILITY TEST RESULTS WHEN TESTING FIVE PATIENTS' SAMPLES' USING ETEST TECHNIQUE. THE CUSTOMER SAID THAT THEY HAD TESTED VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) ISOLATED FROM 5 DIFFERENT PATIENTS' SAMPLES' USING ETEST DAPTOMYCIN DPC 256 US S30 - REFERENCE (B)(4). (LOT#1010146860 - EXPIRATION DATE : 19/07/2025) IN ASSOCIATION WITH MUELLER HINTON PLATES AND THAT THEY HAD OBTAINED DAPTOMYCIN RESISTANT RESULTS. THE CUSTOMER REPORTED THAT THEY HAD NOTICED INCONSISTENT RESULTS WITH DAPTOMYCIN ETEST WHEN USING MUELLER HINTON SMALL PLATES COMPARED WITH MUELLER HINTON LARGE PLATES. LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055280 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  PRODUCT DESCRIPTION: ETEST® IS A MANUAL, QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY OF NON-FASTIDIOUS GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA AND FASTIDIOUS BACTERIA. 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 TESTED ON AGAR MEDIA AFTER OVERNIGHT INCUBATION. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED INCORRECT ANTIBIOTIC SUSCEPTIBILITY TEST RESULTS WHEN TESTING FIVE PATIENTS' SAMPLES' USING ETEST TECHNIQUE. THE CUSTOMER SAID THAT THEY HAD TESTED VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) ISOLATED FROM 5 DIFFERENT PATIENTS' SAMPLES' USING ETEST DAPTOMYCIN DPC 256 US S30 - REFERENCE (B)(4) (LOT#1010146860 - EXPIRATION DATE : 19/07/2025) IN ASSOCIATION WITH MUELLER HINTON PLATES AND THAT THEY HAD OBTAINED DAPTOMYCIN RESISTANT RESULTS. THE CUSTOMER REPORTED THAT THEY HAD NOTICED INCONSISTENT RESULTS WITH DAPTOMYCIN ETEST WHEN USING MUELLER HINTON SMALL PLATES COMPARED WITH MUELLER HINTON LARGE PLATES. LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE CUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055263 ↗
• MalfunctionOct 25, 2023High Test Results; High Test Results

  INTENDED USE. ETEST® IS A MANUAL, QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF ANTIMICROBIAL SUSCEPTIBILITY OF NON-FASTIDIOUS GRAM-NEGATIVE AND GRAM-POSITIVE AEROBIC BACTERIA AND FASTIDIOUS BACTERIA. 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 TESTED ON AGAR MEDIA AFTER OVERNIGHT INCUBATION. DESCRIPTION OF THE ISSUE. A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE RESISTANT DAPTOMYCIN WITH VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) ISOLATES WHEN TESTING THREE PATIENT ISOLATES WITH THE ETEST DAPTOMYCIN DPC 256 US S30 - REFERENCE (B)(4). (LOT#1009977190 - EXPIRATION DATE : 12/04/2025) IN ASSOCIATION WITH MUELLER HINTON PLATES. INDEED, THE CUSTOMER INDICATES HAVING OBTAINED THREE VRE ISOLATES TESTED AS DAPTOMYCIN RESISTANT. THEY ALSO NOTICED INCONSISTENT RESULTS WITH DAPTOMYCIN ETEST WHEN USING SMALL VS LARGE MUELLER HINTON PLATES. CONSIDERING THAT RESISTANT DAPTOMYCIN IS A RARE OCCURRENCE, THE STRAINS WERE SENT TO AN EXTERNAL LABORATORY (ARUP) FOR TESTING. THE BROTH MICRODILUTION RESULTS FROM ARUP WERE SUSCEPTIBLE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002493 ↗