HercepTest™ for the Dako Autostainer K5207Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05700572031994), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2018False Negative Result

  DEVICE INVOLVED IN THIS COMPLAINT: · K5207, HERCEPTEST FOR DAKO AUTOSTAINER. SUMMARY: INCONSISTENT STAINING ON PRODUCT K5207/HERCEPTEST FOR THE DAKO AUTOSTAINER, LOT NO. 20029667, RESULTED IN A FALSE NEGATIVE. THE CUSTOMER RERAN THE PATIENT TISSUE ON THE HERCEPTEST ASSAY WHICH CONFIRMED THE NEGATIVE TEST RESULT. THE CUSTOMER ALSO RAN A FISH TEST ON THE PATIENT TISSUE WHICH RESULTED IN A POSITIVE RESULT. NO MISDIAGNOSIS OCCURRED AS THE PATIENT WAS DIAGNOSED ACCORDING TO THE FISH TESTING. ASSESSMENT: THE CUSTOMER RAN A FISH ON THE SPECIFIC PATIENT TISSUE AFTER THE IHC TISSUE TEST AND RETEST RESULTED AS NEGATIVE FOR HER2. THE FISH TEST INDICATED THE TISSUE WAS POSITIVE. THE CUSTOMER INDICATED THEY THOUGHT THEIR PROCEDURE WAS THE CAUSE OF NEGATIVE TESTS. A SERVICE ENGINEER WAS SENT ON SITE TO WORK WITH THE CUSTOMER. THE SERVICE ENGINEER CONFIRMED THEIR PROCEDURE. NO ROOT CAUSE OR LIKELY ROOT CAUSE WAS IDENTIFIED. THE SERIAL NUMBER OF THE AUTOSTAINER WAS NOT RECORDED IN THE COMPLAINT. AS PART OF ITS INTERNAL REVIEW, DAKO ANALYZED WHETHER THERE WERE ANY ADDITIONAL COMPLAINTS LOGGED ON THE CUSTOMER'S LOT NUMBER AND NO OTHER COMPLAINTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7598042 ↗