MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. FLEX MONOCLONAL MOUSE ANTI-HUMAN CD20CY, CLONE L26, READY-TO-USE (DAKO OMNIS); REAGENT

Model Number	GA604
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
E1 address - line 1: (b)(6).
Event or Problem Description
Agilent learned that the customer, (b)(6), denmark, had conducted a retrospective review of their staining results with the ga604 cd20 staining antibody after they had received borderline results on the nordiqc external quality assessment testing.Due to the nordiqc findings, the customer re-evaluated 358 patient cases to verify the accuracy of previously released results.In march 2025, agilent was informed that one case was identified where the released result was considered questionable.While a questionable result may have impacted the treatment strategy, the clinical details are unknown, and the customer has not been forthcoming in responding to our follow-ups.Agilent has not confirmed that a false negative result was identified.No other information has been provided.
Additional Manufacturer Narrative
The following fields were updated: a1, b4, b5, g1, g3, g6, h2, h6, h7, h11.The associated recall was submitted to the fda and given recall event id (b)(4) on 11-aug-2025.
Event or Problem Description
Additional information was received from the customer via email in october 2025.The customer confirmed "there are no patients who have received a wrong diagnosis as such - we always use more than one b-marker for actual haematopathology, in this case pax5."furthermore, the original allegation that "in 1 patient it could have been significant" and "may have had a minor effect due to slightly changed treatment strategy" has now been confirmed that this was caught via confirmatory testing on an alternate staining platform negating any clinical significance to the patient.The customer's pathologist also corrected that 385 patient cases from 2024 were retrospectively reviewed instead of the initial reported amount of 358.Lastly, the customer clarified that while there is no concern of any incorrect diagnosis being released, they were unable to confirm if any treatment strategies were affected due to a negative cd20 test result differing from the patient's clinical history and other diagnostic tests.Clinical history and other diagnostic tests include clinical findings, tissue morphology, other immunohistochemical markers, and additional testing platforms on samples that are routinely collected during diagnostic work up, like bone marrow and blood.Although the patients' status are unknown, there was no allegation of harm, or impact, as the cases identified in the retrospective review were not considered to have had clinical significance.
Additional Manufacturer Narrative
The following fields were updated: b4, b5, g3, g6, h2, h6, h9, h11.The associated recall recall event id 97421.
Event or Problem Description
This supplemental report is being submitted to document the release of the revised ga604 ifu, rev.5.This new revision includes an additional bullet point in the "precautions" section that makes the user aware that chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll) tissue may express low levels of cd20 leading to variable or undetectable staining.Additionally, it is reiterated in this bullet point that, as per the intended use, the clinical interpretation should be made in conjunction with other diagnostic tests and the patient's clinical history.This release was made available on (b)(6) 2025 and is available with all new us and denmark purchases of the product as well as on the agilent website.
Additional Manufacturer Narrative
The following fields were updated: b4, b5, g3, g6, h2, h6, h11.

• Brand Name: FLEX MONOCLONAL MOUSE ANTI-HUMAN CD20CY, CLONE L26, READY-TO-USE (DAKO OMNIS)
• Common Device Name: REAGENT
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338121
• MDR Report Key: 21964572
• Report Number: 3003423869-2025-00039
• Device Sequence Number: 8160549
• Product Code: NJT
• UDI-Device Identifier: 05700572033042
• UDI-Public: (01)05700572033042(17)230418(10)41582271
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: GA604
• Device Catalogue Number: GA60461-2
• Device Lot Number: 41582271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 10/22/2025; 11/10/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/28/2025; 10/23/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2563-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown