FLEX Mono Mo A-Hu CD20cy Cl L26 RTU (Dako Omnis) GA604Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05700572033042), received between Apr 23, 2025 and May 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 11, 2025Class IIOpen, Classified

   Their is the potential for weak staining which may result in false negative CD20 identification.

   Z-2563-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN DENMARK INITIALLY REPORTED POOR RESULTS FOR THEIR CD20 / GA604 REAGENT WITH NORDIQC IN (B)(6) 2024. NORDIQC NOTED THE STAINING RESULTS WERE "TYPICALLY GIVING FALSE NEGATIVE OR TOO WEAK STAINING REACTION IN THE B-CLL". DUE TO THE NORDIQC FINDINGS, THE CUSTOMER RE-EVALUATED 358 PATIENT CASES TO CONFIRM THEIR RELEASED RESULTS. IN (B)(6) 2025 IT WAS COMMUNICATED TO AGILENT THAT 1 CASE WAS FOUND TO HAVE QUESTIONABLE RESULTS THAT WERE RELEASED TO A PATIENT. THE CUSTOMER'S PATHOLOGIST CONFIRMED, "IN 1 PATIENT IT COULD HAVE BEEN SIGNIFICANT" AND "MAY HAVE HAD A MINOR EFFECT DUE TO SLIGHTLY CHANGED TREATMENT STRATEGY". PATIENT STATUS IS UNKNOWN AT THIS TIME. THE CUSTOMER'S PATHOLOGIST CONFIRMED THE ISSUE HAS BEEN RESOLVED BY HAVING CHANGED THEIR STAINING PLATFORM FOR CD20. NO OTHER INFORMATION OR PICTURES WERE PROVIDED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE NEW RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964572 ↗
• MalfunctionApr 23, 2025False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES OF AMERICA REPORTED THEY HAVE BEEN EXPERIENCING FALSE NEGATIVES ON PATIENT TISSUE USING THE AGILENT CD20 ON THE OMNIS INSTRUMENT. THE CUSTOMER'S PATHOLOGISTS NOTED THAT THE ISSUE WAS FOUND SPECIFICALLY WITH LYMPHOMA CASES. THE LATEST CASE WAS A PROFICIENCY TEST FROM THE COLLEGE OF AMERICAN PATHOLOGISTS (CAP). "ACCORDING TO THE DIAGNOSIS (MORPHOLOGY) OF THE CASE, CD20 SHOULD HAVE BEEN POSITIVE." THE CUSTOMER NOTES THAT THE TONSIL CONTROL ALWAYS STAINS WELL AND NOT ALL TISSUES ARE AFFECTED. THEY RAN THE SAME PATIENT CASE ON A COMPETITOR INSTRUMENT, AND IT STAINED APPROPRIATELY. THE CUSTOMER RESOLVED THE ISSUE BY REDUCING THE PRETREATMENT INCUBATION TIME. THE CUSTOMER CONFIRMED THERE ARE NO CONCERNS OF INCORRECT RESULTS BEING RELEASED TO PATIENTS; "ANY QUESTIONABLE (FALSE NEGATIVE) RESULTS WERE SENT OUT FOR CONFIRMATION OR PAX5 WAS ORDERED FOR VERIFICATION OF DIAGNOSIS." WHILE THERE IS NO INDICATION OF PATIENT HARM REPORTED FOR THIS EVENT, IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE NEW RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895482 ↗
• MalfunctionApr 23, 2025False Negative Result; Improper or Incorrect Procedure or Method; False Negative Result; Improper or Incorrect Procedure or Method

  A CUSTOMER IN CHINA REPORTED THAT ON (B)(6) 2025, THE CD20 STAINING OF A LYMPHOMA PATIENT RESULTED IN POSITIVE STAINING FOR THE TONSIL TISSUE CONTROL, AND INTERNAL CONTROL ON THE PATIENT SAMPLE, BUT STAINED NEGATIVE ON THE PATIENT SAMPLE TUMOR AREA. THIS RESULTED IN THE HOSPITAL RELEASING A NEGATIVE RESULT TO THE PATIENT. THE PATIENT INDEPENDENTLY VISITED ANOTHER HOSPITAL TO CHECK THE RESULTS AND HAD ADDITIONAL STAINING PERFORMED; THE RESULTS OF WHICH SHOWED POSITIVE ON THE TUMOR AREA CONCLUDING IN A POSITIVE RESULT. ON (B)(6) 2025, ONCE MADE AWARE OF THE CONTRADICTORY RESULTS FROM THE PATIENT, THE INITIAL HOSPITAL RE-STAINED SAMPLES OF THE ORIGINAL PATIENT SAMPLE ON 2 DIFFERENT OMNIS INSTRUMENTS AND THE RESULTS WERE THE SAME AS THE JANUARY 10 RESULTS; CONTROLS WERE POSITIVE, AND THE PATIENT SAMPLE TUMOR AREA WAS NEGATIVE. AN AGILENT APPLICATION ENGINEER (AE) VISITED THE SITE TO TROUBLESHOOT THE ISSUE, AND IT WAS CONFIRMED THE CUSTOMER IS USING A CUSTOM PROTOCOL AND NOT THE RECOMMENDED GA604 OMNIS PROTOCOL. WHEN THE CUSTOMER RE-RAN THE TEST WITH THE RECOMMENDED PROTOCOL, THE RESULT WAS A VERY WEAK STAINING. THE AE RE-STAINED THE SAMPLES ON THE AUTOSTAINER INSTRUMENT AND RECEIVED PO

  Patient problems: Insufficient Information

  MAUDE report 21895043 ↗