HistoCore PEARL 000000014049350667Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049188198907), received between Apr 27, 2022 and Sep 12, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Device Ingredient or Reagent Problem; Insufficient Device Problem Information; Device Ingredient or Reagent Problem; Insufficient Device Problem Information

  ON (B)(6) 2025 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT ONE OF OUR CUSTOMERS EXPERIENCED SUBOPTIMAL TISSUE PROCESSING IN ONE RUN ON THEIR HISTOCORE PEARL TISSUE PROCESSOR ON (B)(6) 2025. THROUGH FURTHER COMMUNICATION WITH THE CUSTOMER IT WAS DETERMINED THAT ALSO SAMPLES PROCESSED IN ONE RUN ON (B)(6) 2025, AND SEVERAL SAMPLES PROCESSED BETWEEN (B)(6) 2025 SHOWED SUBOPTIMAL TISSUE PROCESSING. IT WAS FURTHER DETERMINED THAT THE CUSTOMER ONLY USES THE HISTOCORE PEARL FOR THE PROCESSING OF HUMAN NON-CLINICAL TISSUES SAMPLES FOR RESEARCH PURPOSES. THEREFORE NO PATIENTS WERE NEGATIVELY IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036131 ↗
• InjuryAug 25, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ON (B)(6) 2025, LEICA BIOSYSTEMS WAS CONTACTED BY A CUSTOMER REGARDING INCONSISTENT PROCESSING OF TISSUE SAMPLES ON THEIR HISTOCORE PEARL TISSUE PROCESSOR. SOME SAMPLES WERE DESCRIBED AS RAW WHILE OTHERS HAD A BURNED APPEARANCE. ON AUGUST 19 2025, LEICA BIOSYSTEMS WAS INFORMED THAT A TOTAL OF 41 SAMPLES HAD BEEN IMPACTED BY THIS INCIDENT. 40 SAMPLES WERE DIAGNOSABLE. IN THE ONE CASE WHERE A DIAGNOSIS WAS NOT POSSIBLE, A RE-BIOPSY WAS PERFORMED. AFTER COLLECTION OF THE NEW SAMPLE MATERIAL A DIAGNOSIS OF THE PATIENT COULD BE SUCCESFULLY PERFORMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22882753 ↗
• InjuryNov 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, A CUSTOMER REPORTED TO LEICA BIOSYSTEMS THAT ON (B)(6) 2023 THEY EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEARL. AS A RESULT ONE (1) BREAST RESECTION TISSUE SAMPLE WAS LOST, AND IT IS NOT POSSIBLE TO COLLECT TISSUE FROM THE PATIENT AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 18159250 ↗
• InjuryApr 27, 2022Defective Component; Output Problem; Defective Component

  ON (B)(6) 2022, A CUSTOMER REPORTED TO LEICA BIOSYSTEMS THAT ON (B)(6) 2022 THEY EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEARL. AS A RESULT THE TISSUE WAS UNDIAGNOSABLE, AND A REBIOPSY FOR 2 PATIENTS WAS RECOMMENDED.

  Patient problems: Tissue Breakdown

  MAUDE report 14216699 ↗