ETEST® Imipenem/Relebactam (IPR)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03573026049966), received between May 5, 2021 and May 5, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

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

1 other recall cover devices cleared under the same FDA submission (K191953); 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 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-0849-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATED NOTIFIED BIOMERIEUX OF OBTAINING OVERESTIMATED MIC RESULTS IN ASSOCIATION WITH ETEST® IMIPENEM RELEBACTAM IPR US S30 (REF. 420927, LOT 1008390030) WHILE PERFORMING VALIDATION TESTING WITH SEVEN (7) STRAINS OF PSEUDOMONAS AERUGINOSA INCLUDING PSEUDOMONAS AERUGINOSA ATCC® 27853¿. THE CUSTOMER TESTED THE PSEUDOMONAS AERUGINOSA STRAINS TWICE USING 150MM REMEL PLAIN MUELLER HINTON AGAR PLATES AND 0.45% SALINE SOLUTION WITH A MCFARLAND DENSITY OF BETWEEN 0.5 AND 0.53. OVERESTIMATED IMIPENEM RELEBACTAM MIC RESULTS WERE OBTAINED FOR EACH ISOLATE FOR BOTH INITIAL AND REPEAT TESTING. BIOMERIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER TO USE A 0.85% SALINE SOLUTION AS INSTRUCTED IN THE ETEST® IMIPENEM RELEBACTAM IPR US S30 INSTRUCTIONS FOR USE (IFU). THE CUSTOMER REPEATED TESTING USING A 0.85% SALINE SOLUTION FOLLOWING THE INSTRUCTIONS FOR USE. ALL SEVEN (7) ISOLATES OBTAINED OVERESTIMATED MIC RESULTS WITH FOUR (4) FALSE RESISTANT RESULTS INTERPRETED USING THE CLSI 2021 BREAKPOINTS WITH A SUSCEPTIBLE MIC RESULT =2 AND RESISISANT RESULT >8. THE RESULTS OF THE FALSE RESISTANT RESULTS ARE LISTED BELOW. PSEUDOMONAS AERUGINOSA STRAIN 512 EXPECTED RESULT2 UG/ML - SUSCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778547 ↗
• MalfunctionMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATED NOTIFIED BIOMERIEUX OF OBTAINING OVERESTIMATED MIC RESULTS IN ASSOCIATION WITH ETEST® IMIPENEM RELEBACTAM IPR US S30 (REF. 420927, LOT 1008390030) WHILE PERFORMING VALIDATION TESTING WITH SEVEN (7) STRAINS OF PSEUDOMONAS AERUGINOSA INCLUDING PSEUDOMONAS AERUGINOSA ATCC® 27853¿. THE CUSTOMER TESTED THE PSEUDOMONAS AERUGINOSA STRAINS TWICE USING 150MM REMEL PLAIN MUELLER HINTON AGAR PLATES AND 0.45% SALINE SOLUTION WITH A MCFARLAND DENSITY OF BETWEEN 0.5 AND 0.53. OVERESTIMATED IMIPENEM RELEBACTAM MIC RESULTS WERE OBTAINED FOR EACH ISOLATE FOR BOTH INITIAL AND REPEAT TESTING. BIOMERIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER TO USE A 0.85% SALINE SOLUTION AS INSTRUCTED IN THE ETEST® IMIPENEM RELEBACTAM IPR US S30 INSTRUCTIONS FOR USE (IFU). THE CUSTOMER REPEATED TESTING USING A 0.85% SALINE SOLUTION FOLLOWING THE INSTRUCTIONS FOR USE. ALL SEVEN (7) ISOLATES OBTAINED OVERESTIMATED MIC RESULTS WITH FOUR (4) FALSE RESISTANT RESULTS INTERPRETED USING THE CLSI 2021 BREAKPOINTS WITH A SUSCEPTIBLE MIC RESULT =2 AND RESISTANT RESULT >8. THE RESULTS OF THE FALSE RESISTANT RESULTS ARE LISTED BELOW. (B)(6). AS THERE ARE NO PATIENTS ASSOCIATED WITH THESE QUALITY CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778498 ↗
• MalfunctionMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATED NOTIFIED BIOMERIEUX OF OBTAINING OVERESTIMATED MIC RESULTS IN ASSOCIATION WITH ETEST® IMIPENEM RELEBACTAM IPR US S30 (REF. 420927, LOT 1008390030) WHILE PERFORMING VALIDATION TESTING WITH SEVEN (7) STRAINS OF PSEUDOMONAS AERUGINOSA INCLUDING PSEUDOMONAS AERUGINOSA ATCC® 27853¿. THE CUSTOMER TESTED THE PSEUDOMONAS AERUGINOSA STRAINS TWICE USING 150MM REMEL PLAIN MUELLER HINTON AGAR PLATES AND 0.45% SALINE SOLUTION WITH A MCFARLAND DENSITY OF BETWEEN 0.5 AND 0.53. OVERESTIMATED IMIPENEM RELEBACTAM MIC RESULTS WERE OBTAINED FOR EACH ISOLATE FOR BOTH INITIAL AND REPEAT TESTING. BIOMERIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER TO USE A 0.85% SALINE SOLUTION AS INSTRUCTED IN THE ETEST® IMIPENEM RELEBACTAM IPR US S30 INSTRUCTIONS FOR USE (IFU). THE CUSTOMER REPEATED TESTING USING A 0.85% SALINE SOLUTION FOLLOWING THE INSTRUCTIONS FOR USE. ALL SEVEN (7) ISOLATES OBTAINED OVERESTIMATED MIC RESULTS WITH FOUR (4) FALSE RESISTANT RESULTS INTERPRETED USING THE CLSI 2021 BREAKPOINTS WITH A SUSCEPTIBLE MIC RESULT =2 AND RESISISANT RESULT >8. THE RESULTS OF THE FALSE RESISTANT RESULTS ARE LISTED BELOW. PSEUDOMONAS AERUGINOSA STRAIN 512 EXPECTED RESULT2 UG/ML - SUSCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778360 ↗
• MalfunctionMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING OVERESTIMATED MIC RESULTS IN ASSOCIATION WITH ETEST® IMIPENEM RELEBACTAM IPR US S30 (REF. 420927, LOT 1008390030) WHILE PERFORMING VALIDATION TESTING WITH SEVEN (7) STRAINS OF PSEUDOMONAS AERUGINOSA INCLUDING PSEUDOMONAS AERUGINOSA ATCC® 27853¿. THE CUSTOMER TESTED THE PSEUDOMONAS AERUGINOSA STRAINS TWICE USING 150MM REMEL PLAIN MUELLER HINTON AGAR PLATES AND 0.45% SALINE SOLUTION WITH A MCFARLAND DENSITY OF BETWEEN 0.5 AND 0.53. OVERESTIMATED IMIPENEM RELEBACTAM MIC RESULTS WERE OBTAINED FOR EACH ISOLATE FOR BOTH INITIAL AND REPEAT TESTING. BIOMERIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER TO USE A 0.85% SALINE SOLUTION AS INSTRUCTED IN THE ETEST® IMIPENEM RELEBACTAM IPR US S30 INSTRUCTIONS FOR USE (IFU). THE CUSTOMER REPEATED TESTING USING A 0.85% SALINE SOLUTION FOLLOWING THE INSTRUCTIONS FOR USE. ALL SEVEN (7) ISOLATES OBTAINED OVERESTIMATED MIC RESULTS WITH (4) FALSE RESISTANT RESULTS INTERPRETED USING THE CLSI 2021 BREAKPOINTS WITH A SUSCEPTIBLE MIC RESULT =2 AND RESISTANT RESULT >8. THE RESULTS OF THE FALSE RESISTANT RESULTS ARE LISTED: PSEUDOMONAS AERUGINOSA STRAIN 512. EXPECTED RESULT 2 G/ML - SUSCEPTIBLE. RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778171 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191953. One submission often covers many models, so check the product and lot details in each record.

• Z-2226-2021 · Jun 24, 2021 · Terminated
  ETEST IMIPENEM RELEBACTAM. in vitro diagnostic