CIDEX™ 20392Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705037045553), received between Nov 16, 2018 and Oct 10, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 10, 2023Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED AN EXPIRED CIDEX¿ OPA TEST STRIP WAS USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION. NO PERFORMANCE ISSUES WERE REPORTED; THE CUSTOMER STATED, ¿THE RESULT WAS AS EXPECTED,¿ AND THE AFFECTED LOAD WAS RELEASED FOR PATIENT USE. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED, AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905623 ↗
• MalfunctionAug 26, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT WHERE EXPIRED CIDEX¿ OPA TEST STRIPS WERE USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION, AND TWO AFFECTED PROBES WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENTS ASSOCIATED WITH THIS ISSUE. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303517 ↗
• MalfunctionJul 19, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED TWO EVENTS WHERE EXPIRED CIDEX¿ OPA TEST STRIPS WERE USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION, AND THE AFFECTED SCOPES WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENTS ASSOCIATED WITH THIS ISSUE. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE SECOND EVENT AT THE CUSTOMER FACILITY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2022-00210 FOR THE FIRST EVENT RELATED TO THIS USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060140 ↗
• MalfunctionJul 19, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED TWO EVENTS WHERE EXPIRED CIDEX¿ OPA TEST STRIPS WERE USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION, AND THE AFFECTED SCOPES WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENTS ASSOCIATED WITH THIS ISSUE. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE FIRST EVENT AT THE CUSTOMER FACILITY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2022-00211 FOR THE SECOND EVENT RELATED TO THIS USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060114 ↗
• MalfunctionSep 13, 2019Expiration Date Error; Expiration Date Error

  A CUSTOMER REPORTED USING EXPIRED CIDEX® OPA TEST STRIPS TO TEST THEIR CIDEX® OPA SOLUTION AND THE INSTRUMENTS THAT WERE CLEANED IN THE TESTED CIDEX® OPA SOLUTION WERE RELEASED AND USED ON 4-6 PATIENTS. THEY STATED QUALITY CONTROL TESTING WAS PERFORMED WHEN THE CIDEX® OPA TEST STRIP BOTTLE WAS OPENED, AND THE OPEN DATE AND DO NOT USE AFTER DATE WERE DOCUMENTED. HOWEVER, IT WAS NOT NOTICED THAT THE DO NOT USE AFTER DATE WAS AFTER THE MANUFACTURER EXPIRATION DATE MARKED ON THE BOTTLE AND THE CUSTOMER DID NOT REALIZE THE STRIPS WERE EXPIRED UNTIL AFTER THEY WERE USED. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE AT THIS TIME. THE CUSTOMER CONFIRMED THEY HAVE DISCARDED ANY REMAINING EXPIRED CIDEX® OPA TEST STRIPS AND WAS REMINDED TO FOLLOW THE INSTRUCTIONS FOR USE (IFU) WHICH STATES THE UNUSED CIDEX® OPA TEST STRIPS SHOULD BE DISCARDED AFTER THE EXPIRATION DATE ON THE OUTSIDE OF THE BOTTLE EVEN IF IT HAS NOT REACHED THE 90-DAY OPEN DATE. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE THEY CANNOT GUARANTEE HIGH-LEVEL DISIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9035119 ↗
• MalfunctionNov 16, 2018Expiration Date Error; Device Handling Problem; Expiration Date Error; Device Handling Problem

  A CUSTOMER REPORTED USING EXPIRED CIDEX® OPA TEST STRIPS TO TEST THEIR CIDEX® OPA SOLUTION AND THE INSTRUMENTS THAT WERE CLEANED IN THE TESTED CIDEX® OPA SOLUTION WERE RELEASED AND USED ON PATIENTS. THEY STATED THEY USED THE TEST STRIPS BECAUSE THE INSTRUCTIONS FOR USE (IFU) STATES THE STRIPS CAN BE USED FOR 90-DAYS AFTER OPENING THE BOTTLE, AND THE CIDEX® OPA STRIPS CAME OUT POSITIVE (OR PURPLE) INDICATING THE CIDEX® OPA SOLUTION MEETS THE MINIMUM EFFECTIVE CONCENTRATION (MEC). THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. THE CUSTOMER WAS ADVISED TO DISCARD ANY REMAINING CIDEX® OPA TEST STRIPS AND TO FOLLOW THE INSTRUCTIONS FOR USE (IFU) WHICH STATES THE UNUSED CIDEX® OPA TEST STRIPS SHOULD BE DISCARDED AFTER THE EXPIRATION DATE ON THE OUTSIDE OF THE BOTTLE EVEN IF IT HAS NOT REACHED THE 90-DAY OPEN DATE. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE THEY CANNOT GUARANTEE HIGH-LEVEL DISINFECTION HAS BEEN ACHIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8078374 ↗