MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC. ULTRAVIEW UNIVERSAL ALKALINE PHOSPHATASE RED DETECTION KIT; IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Catalog Number	05269814001
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable staining results with the ultraview universal alkaline phosphatase red detection kit using the benchmark ultra instrument.The initial testing of a patient block showed false-negative results for several markers, although the controls were positive.A repeat staining with a different lot of the same detection kit yielded the expected positive results.
Additional Manufacturer Narrative
Data analysis revealed that the ultraview universal ap red detection kit (05269814001), lot n04707, was compliant with all quality criteria at the time of release.Review of the electronic batch record did not indicate any non-conformances or manufacturing issues that would contribute to this issue.Review of the antibody assays used in the testing indicated three roche/ventana assays: anti-melanosome (hmb45), lot n09753, cintec p-16 histology, lot n06466, and prame (epr20330), lot n16180.It was noted that the incubation time for the anti-melanosome (hmb45), lot n09753, assay was 12 minutes in the customer protocol but 8 minutes in the product method sheet.The protocol used for prame (epr20330), lot n16180, was aligned with the method sheet.The protocol used for cintec p-16 histology included 36 minutes of antibody incubation compared to 20 minutes recommended in the method sheet.The assays for ki-67 and sox10 were performed using prep-kits, which are user-filled, third-party antibodies.The order of the slides on the run was also evaluated, but did not indicate a clear pattern of staining, which would indicate degradation or empty with test remaining issues.The appropriate staining occurring on the same instrument with a new detection kit likewise rules out an instrument issue.Due to the appropriate staining produced with the same antibodies and a new lot of ultraview universal ap red detection kit (05269814001), a possible cause for the inconsistent results is a dispenser failure in the original detection kit.

• Brand Name: ULTRAVIEW UNIVERSAL ALKALINE PHOSPHATASE RED DETECTION KIT
• Common Device Name: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 24664414
• Report Number: 2028492-2026-01035
• Device Sequence Number: 21154739
• Product Code: NJT
• UDI-Device Identifier: 04015630972258
• UDI-Public: 04015630972258
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2026
• Device Catalogue Number: 05269814001
• Device Lot Number: N04707
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown