RAPIDEC® CARBA NPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026464370), received between Feb 5, 2019 and Oct 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionOct 12, 2021False Positive Result; False Positive Result

  INTENDED USE: RAPIDEC® CARBA NP IS A PHENOTYPIC (COLORIMETRIC) IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF CARBAPENEMASE ENZYMES IN ENTEROBACTERIACEAE AND PSEUDOMONAS AERUGINOSA COLONIES THAT HAVE ELEVATED MIC VALUES TO ANY CARBAPENEM. RAPIDEC® CARBA NP IS PERFORMED ON PURE COLONIES GROWN ON NON-SELECTIVE SHEEP BLOOD AGAR CULTURE MEDIA. RAPIDEC® CARBA NP IS INTENDED AS AN AID IN THE PREVENTION AND CONTROL OF INFECTION CAUSED BY CARBAPENEMASE-PRODUCING ENTEROBACTERIACEAE AND PSEUDOMONAS AERUGINOSA. RAPIDEC® CARBA NP IS NOT INTENDED TO GUIDE OR MONITOR THE TREATMENT FOR THESE BACTERIAL INFECTIONS. A NEGATIVE RESULT DOES NOT PRECLUDE THE PRESENCE OF CARBAPENEMASE ENZYMES. THE ABILITY OF THE RAPIDEC® CARBA NP TO DETECT CARBAPENEMASES ENZYMES ENCODED BY GENETIC MARKER OTHER THAN KPC, NDM, OXA-48, VIM AND IMP HAS NOT BEEN ESTABLISHED. RAPIDEC® CARBA NP TESTING SHOULD BE USED IN CONJUNCTION WITH OTHER LABORATORY TESTS INCLUDING ANTIMICROBIAL SUSCEPTIBILITY TESTING. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR A PROTEUS MIRABILIS STRAIN IN ASSOCIATION WITH THE RAPIDEC® CARBA NP (10) US (REF 417824, LOT 1008199570). T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619526 ↗
• MalfunctionFeb 5, 2019False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A FALSE NEGATIVE RESULT FOR A KLEBSIELLA PNEUMONIA ISOLATE IN ASSOCIATION WITH THE RAPIDEC® CARBA NP PRODUCT. THE CUSTOMER STATED THEY TESTED THE KLEBSIELLA PNEUMONIA ISOLATE TWICE WITH MICROSCAN; THE RESULT INDICATED A POSSIBLE CARBAPENEM RESISTANT ENTEROBACTERIACEAE (CRE). TESTING WITH RAPIDEC CARBA NP PROVIDED A "NEGATIVE" RESULT. THE RESULT PROVIDED TO THE PHYSICIAN WAS "CRE WITH CARBA NP TEST NEGATIVE". THE PATIENT ISOLATE WAS SENT TO AN EXTERNAL LABORATORY FOR FURTHER TESTING BECAUSE THE CUSTOMER REMAINED SUSPICIOUS OF CRE. PCR TESTING WAS PERFORMED = POSITIVE FOR OXA 48 CARBAPENEMASE. THE REPORT TO PHYSICIAN WAS MODIFIED THAT PCR TESTING WAS CRE POSITIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8304917 ↗