HercepTest™ for Automated Link Plarforms SK001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05700572032007), received between Nov 17, 2015 and Sep 8, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Unclear Information; Unclear Information

  COMPANY REPRESENTATIVE REPORTED UNNECESSARY GASTRIC BIOPSY PROCEDURE. PATIENT SAMPLE WAS TESTED FOR HER2 UTILIZING THE PRODUCT HERCEPTEST (SK001). THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES THE SAMPLES SHOULD BE "FIXED FOR 18-24 HOURS IN NEUTRAL-BUFFERED FORMALIN" AND ALSO MENTIONS THAT "BIOPSY SAMPLES IN A TOGA TRIAL WERE FIXED FOR 6-8 HOURS". THE USER MISINTERPRETED THE IFU BY APPLYING THE TOGA TRIAL CRITERIA FOR BIOPSY SPECIMEN FIXATION. AS A RESULT, PATIENT BEING TESTED FOR ELIGIBILITY IN A CLINICAL TRIAL HAD THE ORIGINAL SPECIMEN DISQUALIFIED WHICH RESULTED IN AN UNNECESSARY BIOPSY PROCEDURE. PATIENT EXPERIENCED NO ADVERSE EFFECTS FROM THE RE-BIOPSY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442934 ↗
• MalfunctionJun 13, 2018False Negative Result; Device Operates Differently Than Expected

  DEVICE INVOLVED IN THIS COMPLAINT: SK001, HERCEPTEST (RUN ON AUTOSTAINER LINK 48 INSTRUMENT). SUMMARY: INCONSISTENT STAINING ON THE SK001 HERCEPTEST ASSAY, RUN ON THE AUTOSTAINER LINK 48 INSTRUMENT (AS48), RESULTED IN A FALSE NEGATIVE RESULT. THE CUSTOMER RERAN THE PATIENT TISSUE USING A VENTANA ASSAY, WHICH RESULTED IN A STRONG POSITIVE, WHICH WAS SUBSEQUENTLY CONFIRMED AS POSITIVE WITH FISH TESTING. THERE WAS NO PATIENT HARM AS THE CUSTOMER COMPLETED THE TESTS WITHIN A CLINICALLY INSIGNIFICANT TIME FRAME AND THE ISSUE WAS RESOLVED WITHOUT MISDIAGNOSIS. ASSESSMENT: A FALSE NEGATIVE TEST RESULT WAS OBTAINED WITH PRODUCT SK001, HERCEPTEST FOR AUTOMATED LINK PLATFORMS, LOT NO. 20026157. THE CUSTOMER OBSERVED WEAK STAINING ON THE PATIENT TISSUE AND RETESTED THE TISSUE WITH A COMPETITOR, VENTANA, ASSAY. AS THE VENTANA ASSAY TESTED POSITIVE, THE CUSTOMER SENT THE TISSUE FOR FISH TESTING WHICH INDICATED THE TISSUE WAS POSITIVE, HER2 GENE AMPLIFIED. INVESTIGATION RESULTS: A COMPLAINT REVIEW OF THE ASSAY LOT NUMBER WAS PERFORMED AND NO OTHER COMPLAINTS WERE LOGGED ON THIS SK001 ASSAY LOT NUMBER. INFORMATION WAS PROVIDED THAT THE LABORATORY ONLY RUNS GASTRIC TISSUE AS A CONTROL. THE LABORAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7598050 ↗
• Dec 4, 2015Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2015 BIOPSY STAINED WITH HERCEPTEST LOT 20018877 AT (B)(6) GAVE HER2 SCORE 3+, STRONGLY POSITIVE. BASED UPON THE HERCEPTEST RESULT, THE PATIENT WAS TREATED WITH HERCEPTIN. THE PATIENT DID NOT RESPOND TO TREATMENT. ON (B)(6) 2015 TISSUE STAINED WITH ZYTOLIGHT SPEC HER2/CEN17 DUAL COLOR PROBE AT (B)(6) GAVE RESULTS NOT HER2 GENE AMPLIFIED. IT IS NOT YET KNOWN IF THE FISH TEST AND THE HERCEPT TEST WERE DONE ON THE SAME TISSUE SAMPLE, NOR WHAT PERCENT STAINING WAS SEEN WITH THE HERCEPT TEST. (B)(4).

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 5266278 ↗
• Dec 3, 2015Incorrect, Inadequate or Imprecise Result or Readings

  ON 2015 (B)(6) BIOPSY STAINED WITH HERCEPTEST LOT 20016932 AT (B)(6) GAVE RESULT HER2 SCORE 3+, STRONGLY POSITIVE. BASED UPON THE INITIAL HERCEPTEST RESULT, THE PATIENT WAS TREATED WITH HERCEPTIN. THE PATIENT DID NOT RESPOND TO TREATMENT AND ON 2015 (B)(6) PATIENT WAS RETESTED WITH SURGICAL TISSUE STAINED WITH HERCEPTEST LOT 20022527 AND RECEIVED HER2 NEGATIVE RESULTS. MOREOVER, ON 2015 (B)(6) SURGICAL TISSUE STAINED WITH ZYTOLIGHT SPEC HER2/CEN17 DUAL COLOR PROBE AT (B)(6) RESULT: NOT HER2 GENE AMPLIFIED. (DAKO COMPLAINT NUMBER (B)(4)).

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 5266164 ↗
• Nov 17, 2015Incorrect, Inadequate or Imprecise Result or Readings

  A COMPLAINT HAS BEEN RECEIVED FROM A CUSTOMER STATING THAT A BREAST CANCER SPECIMEN FROM A PATIENT WAS INTERPRETED AS NEGATIVE FOR HER2 PROTEIN OVEREXPRESSION (0 STAINING INTENSITY) WHEN TESTED WITH TWO LOTS OF SK001 ((B)(4)) BUT THE SAME SPECIMEN WAS FOUND TO BE HER2 GENE-AMPLIFIED WHEN TESTED WITH A FISH-BASED ASSAY. THE CUSTOMER REPORTED THAT THE DAKO-SUPPLIED CONTROL SLIDE (WITH CANCER CELL LINES 0, 1+, 3+) WAS WORKING CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5230954 ↗