Tomcat® TOMCAT SYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15420045504677), received between Sep 18, 2018 and Sep 29, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940948 ↗
• InjurySep 29, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940930 ↗
• InjurySep 29, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939581 ↗
• InjurySep 16, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788946 ↗
• InjuryAug 25, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439122 ↗
• InjuryAug 25, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438935 ↗
• MalfunctionAug 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301936 ↗
• MalfunctionApr 28, 2026Mechanical Problem

  ON (B)(6) 2026, A CUSTOMER REPORTED CONTAMINATION FROM THE TOMCAT INSTRUMENT (SN: (B)(6). THE CUSTOMER NOTICED MULTIPLE SAMPLES ALIQUOTED FROM THE TOMCAT RETURNED WITH A HIGHER PREVALENCE OF TRICHOMONAS VAGINALIS POSITIVE RESULTS. THE CUSTOMER OBSERVED THAT THE TOMCAT PIPETTE TIPS LEFT A ¿DRAGGING¿ TRAIL OF DRIED LIQUID, THE PIPETTOR MOTION/ MOVEMENT APPEARED INCONSISTENT AND THERE WERE NO INSTRUMENT ERRORS DUE TO THIS ISSUE. THE CUSTOMER AGREED TO PUT THE RESULT REPORTING ON HOLD AND NOT TO USE THE TOMCAT INSTRUMENT UNTIL SERVICE WAS PERFORMED. ON (B)(6) 2026, A HOLOGIC FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED CUSTOMER¿S OBSERVATION. FSE SERVICED THE INSTRUMENT. THE INSTRUMENT PASSED VERIFICATION TESTING AND WAS CONFIRMED OPERATIONAL BEFORE BEING RELEASED BACK TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021262 ↗
• InjurySep 18, 2018Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER COMPLAINED THAT AFTER THEIR THINPREP VIALS WERE FINISHED PROCESSING BY THE TOMCAT INSTRUMENT, THE RETURNED VIALS WERE RECAPPED TOO TIGHT. THIS CAUSED THEIR CYTOLOGISTS TO EXPERIENCE PAIN IN THEIR WRISTS WHEN UNCAPPING THE VIALS. ONE CYTOTECH HAS ASKED FOR MEDICAL ATTENTION AND BEEN DIAGNOSED WITH CARPAL TUNNEL SYNDROME THAT COULD BE ATTRIBUTED WITH UNCAPPING THESE VIALS. PER RISK ASSESSMENT, THE SEVERITY OF THIS RISK IS SERIOUS WHERE TIGHTLY CAPPED THINPREP VIALS COULD HAVE RESULTED IN A CUSTOMER SEEKING MEDICAL INTERVENTION AND BEING DIAGNOSED WITH CARPAL TUNNEL SYNDROME. HOWEVER, THE PROBABILITY OF HARM IS REMOTE AS BEING DIAGNOSED WITH CARPAL TUNNEL SYNDROME WHILE JUST UNCAPPING THINPREP VIALS IS UNLIKELY BUT POSSIBLE TO OCCUR OVER THE LIFETIME OF THE PRODUCT. FURTHER INVESTIGATION INTO THIS ISSUE IS ONGOING.

  Patient problems: Disability; Patient Problem/Medical Problem

  MAUDE report 7887349 ↗