Chemdye® CD42Recalls & reported problems
Terragene S.A. · Chemical Indicator strip for monitoring hydrogen peroxide sterilization processes. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07798164672890), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CHEMICAL INDICATOR DID NOT CHANGE ITS COLOR AFTER A STERILIZATION CYCLE. THE LOAD WAS REPROCESSED. NO FURTHER INFORMATION WAS GATHERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18477384 ↗
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- Comply™ 12483m Company · Indicator, physical/chemical sterilization process1 recall0 reports
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- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.