Rapicide PA Test Strips ML02-0118Recalls & reported problems
Medivators Inc. · Rapicide PA Test Strips · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10677964064071), received between May 9, 2018 and Jun 26, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method2
- Shelf Life Exceeded2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2018Shelf Life Exceeded; Improper or Incorrect Procedure or Method; Shelf Life Exceeded; Improper or Incorrect Procedure or Method
A FACILITY REPORTED USING EXPIRED RAPICIDE PA HIGH LEVEL DISINFECTANT TEST STRIPS FOR CHECKING THE MINIMUM REQUIRED CONCENTRATION (MRC) OF RAPICIDE PA HLD USED IN THEIR AUTOMATED ENDOSCOPE REPROCESSOR. HLD USED WITH THEIR AER WAS NOT PROPERLY VERIFIED FOR MRC, THUS THERE IS POTENTIAL THAT ENDOSCOPES WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7639885 ↗InjuryMay 9, 2018Shelf Life Exceeded; Improper or Incorrect Procedure or Method; Shelf Life Exceeded; Improper or Incorrect Procedure or Method
MEDIVATORS FIELD SERVICE ENGINEER REPORTED, WHILE ON SITE SERVICING THE FACILITY'S ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR, THE FACILITY HAD BEEN USING EXPIRED TEST STRIPS TO CHECK THE MINIMUM REQUIRED CONCENTRATION (MRC) OF RAPICIDE PA HIGH LEVEL DISINFECTANT USED IN THE AER. THERE IS POTENTIAL THAT HLD USED WITH THEIR AER WAS NOT PROPERLY VERIFIED FOR MRC, THUS THERE IS POTENTIAL THAT ENDOSCOPES WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7498577 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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