Tissue-Tek® Paraform® 7020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00615233081001), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Recent adverse event reports

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

• InjuryJul 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SAKURA FINETEK EUROPE B.V. BECAME AWARE ON (B)(6) 2023 THAT PATIENT TISSUE WAS NOT DIAGNOSABLE AND POTENTIALLY A REBIOPSY WOULD BE NEEDED. ON (B)(6) 2023, A DANISH CUSTOMER REPORTED THAT THE LID OF TWO 7020-7021 TISSUE-TEK PARAFORM BIOPSY-STANDARD CASSETTE OPENED IN THE TISSUETEK AUTOTEC A120 INSTRUMENT (AN AUTOMATED EMBEDDING SYSTEM), CAUSING THE TISSUE TO COME OUT OF THE CASSETTE. THE APPLICATION SPECIALIST WAS CALLED ON (B)(6) 2023 AFTER A THIRD CASSETTE LID HAD OPENED. A FIELD SERVICE ENGINEER VISITED THE CUSTOMER ON (B)(6) 2023 TO CHECK THE INSTRUMENT AND TAKE THE LOG FILES FOR INVESTIGATION. HE CONCLUDED THAT THE TISSUE-TEK A120 INSTRUMENT WAS WORKING AS INTENDED WITHIN SPECIFICATION, NOT CAUSING THE CASSETTE LIDS TO OPEN DURING USE OF THE INSTRUMENT. HE DID HOWEVER DISCOVER THAT THE TISSUE INSIDE THE CASSETTE WAS ON THE THICK SIDE (NO PICTURES), AND THE TEMPERATURE IN THE ROOM WAS ALSO 30+ DEGREES ON THE DAYS ON THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398264 ↗