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Comply™ 1233LFRecalls & reported problems

3m Company · 3M™ Comply™ Bowie-Dick Test Pack 1233LF · 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 30707387584154), received between Mar 22, 2019 and Mar 22, 2019 — classified as 1 malfunction.

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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 22, 2019Incorrect, Inadequate or Imprecise Result or Readings

    REPORTED THAT THE BOWIE DICK COMPLY TEST FAILED 4 TIMES IN 3 DIFFERENT STERILIZERS. ALL TESTS CAME FROM THE SAME BOX WITH THE SAME LOT #. AFTER EACH FAILURE, EACH STERILIZER WAS INSPECTED/EXAMINED BY THE MANUFACTURER'S SERVICE TECHNICIAN. THE TECHNICIAN FOUND NOTHING WRONG WITH ANY OF THE 3 STERILIZERS AND RECOMMENDED THAT THE BOWIE DICK TEST FROM A DIFFERENT LOT # BE RUN IN ALL 3 AUTOCLAVES. THIS WAS DONE AND ALL THREE PASSED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8443242 ↗

Other Indicator, physical/chemical sterilization process devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.