BOND™ PA0571Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05055331327901), received between Jan 28, 2022 and Jan 28, 2022 — classified as 4 injuries.

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 16, 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.

• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, LEICA BIOSYSTEMS (LBS) RECEIVED AN EMAIL FROM THE LABORATORY SUPERVISOR DETAILING THAT THE LABORATORY WAS EXPERIENCING STAINING ISSUES THE C-ERB-2 CLONE CB11 ANTIBODY PRODUCT NUMBER PA0571 AND WERE CONCERNED THAT THERE MAY BE TWO MISDIAGNOSED PATIENTS DUE TO OVERSTAINING WITH THIS ANTIBODY, WHICH HAD RESULTED IN FALSE POSITIVE RESULTS. ADDITIONAL DETAILS PROVIDED BY THE LABORATORY SUPERVISOR STATED, "... THAT THEY HAD A PATIENT THAT WAS MISDIAGNOSED ON (B)(6) 2021 ACCORDING TO A POSITIVE HER-2 RESULT. THE PATIENT RECEIVED CHEMOTHERAPY BASED ON THE POSITIVE RESULT. ON (B)(6) 2021 THERE WAS A 2ND PATIENT WITH QUESTIONABLE RESULTS. THE CLINICIAN ASKED FOR A REPEAT OF THE 2ND PATIENT SPECIMEN WHICH TURNED OUT TO BE NEGATIVE. THE NEGATIVE RESULT FROM THE 2ND PATIENT PROMPTED THE LAB TO RE-TEST THE 1ST PATIENT FROM (B)(6). THE REPEAT SPECIMEN FROM (B)(6) WAS NEGATIVE. THE CLINICIAN WAS NOTIFIED OF THE CORRECTED RESULT. THE CLINICIAN INFORMED THE LAB THE PATIENT HAD ALREADY STARTED CHEMOTHERAPY." PATIENT IDENTIFIER INFORMATION WAS PROVIDED FOR EACH OF THE TWO (2) AFFECTED PATIENTS. REFER TO IMPORTER REPORT NUMBER, (B)(4) FOR DETAILS OF THE OTHER PATIENT INVOLVED. THE LEICA

  Patient problems: Insufficient Information

  MAUDE report 13388377 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, LEICA BIOSYSTEMS (LBS) RECEIVED AN EMAIL FROM THE LABORATORY SUPERVISOR DETAILING THAT THE LABORATORY WAS EXPERIENCING STAINING ISSUES THE C-ERB-2 CLONE CB11 ANTIBODY PRODUCT NUMBER PA0571 AND WERE CONCERNED THAT THERE MAY BE TWO MISDIAGNOSED PATIENTS DUE TO OVERSTAINING WITH THIS ANTIBODY, WHICH HAD RESULTED IN FALSE POSITIVE RESULTS. ADDITIONAL DETAILS PROVIDED BY THE LABORATORY SUPERVISOR STATED, "... THAT THEY HAD A PATIENT THAT WAS MISDIAGNOSED ON (B)(6) 2021 ACCORDING TO A POSITIVE HER-2 RESULT. THE PATIENT RECEIVED CHEMOTHERAPY BASED ON THE POSITIVE RESULT. ON (B)(6) 2021 THERE WAS A 2ND PATIENT WITH QUESTIONABLE RESULTS. THE CLINICIAN ASKED FOR A REPEAT OF THE 2ND PATIENT SPECIMEN WHICH TURNED OUT TO BE NEGATIVE. THE NEGATIVE RESULT FROM THE 2ND PATIENT PROMPTED THE LAB TO RE-TEST THE 1ST PATIENT FROM (B)(6). THE REPEAT SPECIMEN FROM (B)(6) WAS NEGATIVE. THE CLINICIAN WAS NOTIFIED OF THE CORRECTED RESULT. THE CLINICIAN INFORMED THE LAB THE PATIENT HAD ALREADY STARTED CHEMOTHERAPY." PATIENT IDENTIFIER INFORMATION WAS PROVIDED FOR EACH OF THE TWO (2) AFFECTED PATIENTS. REFER TO IMPORTER REPORT NUMBER, (B)(4) FOR DETAILS OF THE OTHER PATIENT INVOLVED. THE LEICA

  Patient problems: Insufficient Information

  MAUDE report 13387982 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 AT 1:39PM EASTERN I RECEIVED AN EMAIL FROM (B)(6), LAB SUPERVISOR STATING THAT THEY HAD A PATIENT THAT WAS MISDIAGNOSED ON (B)(6) 2021 ACCORDING TO A POSITIVE HER-2 RESULT. THE PATIENT RECEIVED CHEMOTHERAPY BASED ON THE POSITIVE RESULT. ON (B)(6) 2021 THERE WAS A 2ND PATIENT WITH QUESTIONABLE RESULTS. THE CLINICIAN ASKED FOR A REPEAT OF THE 2ND PATIENT SPECIMEN WHICH TURNED OUT TO BE NEGATIVE. THE NEGATIVE RESULT FROM THE 2ND PATIENT PROMPTED THE LAB TO RE-TEST THE 1ST PATIENT FROM (B)(6). THE REPEAT SPECIMEN FROM (B)(6) WAS NEGATIVE. THE CLINICIAN WAS NOTIFIED OF THE CORRECTED RESULT. THE CLINICIAN INFORMED THE LAB THE PATIENT HAD ALREADY STARTED CHEMOTHERAPY. THUS BRINGING US TO CURRENT STATUS. REFER TO REPORT MRF 3004859032 2022 0001 FOR DETAILS OF PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 13385174 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 AT 1:39PM EASTERN I RECEIVED AN EMAIL FROM (B)(6) LAB SUPERVISOR STATING THAT THEY HAD A PATIENT THAT WAS MISDIAGNOSED ON (B)(6) 2021 ACCORDING TO A POSITIVE HER-2 RESULT. THE PATIENT RECEIVED CHEMOTHERAPY BASED ON THE POSITIVE RESULT. ON (B)(6) 2021 THERE WAS A 2ND PATIENT WITH QUESTIONABLE RESULTS. THE CLINICIAN ASKED FOR A REPEAT OF THE 2ND PATIENT SPECIMEN WHICH TURNED OUT TO BE NEGATIVE. THE NEGATIVE RESULT FROM THE 2ND PATIENT PROMPTED THE LAB TO RE-TEST THE 1ST PATIENT FROM (B)(6). THE REPEAT SPECIMEN FROM (B)(6) WAS NEGATIVE. THE CLINICIAN WAS NOTIFIED OF THE CORRECTED RESULT. THE CLINICIAN INFORMED THE LAB THE PATIENT HAD ALREADY STARTED CHEMOTHERAPY. THUS BRINGING US TO CURRENT STATUS. REFER TO REPORT 3004859032 2022 00002 FOR DETAILS OF THE OTHER PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 13384756 ↗