BOND-PRIME automated stainerRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09349458004828), received between Nov 26, 2025 and Nov 26, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Calibration 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Off-Label Use; Calibration Problem; Off-Label Use; Calibration Problem

  ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "FALSE POSITIVE ON HER 2 CORRELATING WITH ASI IMAGER." THE INFORMATION AVAILABLE DOES NOT IDENTIFY THE SPECIFIC STAINING RUN(S) WHERE "FALSE POSITIVE ON HER 2" WAS REPORTED BY THE CUSTOMER. PER THE CUSTOMER THE INFORMATION DETAILS OF THIS EVENT RESULTED IN A 23-24% INCREASE IN POSITIVE CASES FROM "LAST YEAR." THE CUSTOMER DOCUMENTED THEY WERE CONTACTED BY THE CLINICIAN WITH CONCERNS AS COMPARED TO LAST YEAR "...THEIR HER2 POSITIVE PERCENTAGES WERE HIGH...COMPARING WHAT THEIR ASI IMAGING SCANNER SCORED THEM AS VS WHAT THEIR SENT-OUT TEST RESULTS WERE FROM [LABORATORY]. [LABORATORY] STATING THAT THEY WERE EQUIVOCAL, FISH NEGATIVE. CUSTOMER SAID THAT THEIR HER2 BREAST CASES THAT WERE SCORED 2+ REALLY STATED AS LOW 3+ ON THEIR IMAGING SYSTEM. PATIENTS UNDERWENT TREATMENT AS SUCH." TWENTY (20) PATIENT CASES HAVE BEEN AFFECTED, WITH "PATIENT'S GIVEN TREATMENT, TREATMENT MORE TOXIC ON PATIENT'S ALREADY UNDERGOING TREATMENTS." INFORMATION PROVIDED BY THE LEICA SENIOR APPLICATIONS SPECIALIST DETAILED THE "CUSTOMER WAS MADE AWARE THAT THIS WAS A CLASS I QUALITATIVE ANTIBODY USED ON THEIR BOND PRIME INSTRUMENT. I MADE SURE T

  Patient problems: Insufficient Information

  MAUDE report 23661348 ↗
• InjuryNov 26, 2025Off-Label Use; Calibration Problem; Off-Label Use; Calibration Problem

  ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED ¿FALSE POSITIVE ON HER 2 CORRELATING WITH ASI IMAGER¿. THE INFORMATION AVAILABLE DOES NOT IDENTIFY THE SPECIFIC STAINING RUN(S) WHERE ¿FALSE POSITIVE ON HER 2¿ WAS REPORTED BY THE CUSTOMER. PER THE CUSTOMER THE INFORMATION DETAILS OF THIS EVENT RESULTED IN A 23-24% INCREASE IN POSITIVE CASES FROM ¿LAST YEAR¿. THE CUSTOMER DOCUMENTED THEY WERE CONTACTED BY THE CLINICIAN WITH CONCERNS AS COMPARED TO LAST YEAR ¿¿THEIR HER2 POSITIVE PERCENTAGES WERE HIGH...COMPARING WHAT THEIR ASI IMAGING SCANNER SCORED THEM AS VS WHAT THEIR SENT OUT TEST RESULTS WERE FROM [LABORATORY]. [LABORATORY] STATING THAT THEY WERE EQUIVOCAL, FISH NEGATIVE. CUSTOMER SAID THAT THEIR HER2 BREAST CASES THAT WERE SCORED 2+ REALLY STATED AS LOW 3+ ON THEIR IMAGING SYSTEM. PATIENTS UNDERWENT TREATMENT AS SUCH.¿ TWENTY (20) PATIENT CASES HAVE BEEN AFFECTED, WITH ¿PATIENT¿S GIVEN TREATMENT, TREATMENT MORE TOXIC ON PATIENT¿S ALREADY UNDERGOING TREATMENTS.¿ INFORMATION PROVIDED BY THE LEICA SENIOR APPLICATIONS SPECIALIST DETAILED THE ¿CUSTOMER WAS MADE AWARE THAT THIS WAS A CLASS I QUALITATIVE ANTIBODY USED ON THEIR BOND PRIME INSTRUMENT. I MADE SURE TO

  Patient problems: Insufficient Information

  MAUDE report 23659211 ↗