MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6801756
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros prostatic specific antigen (psa) results were obtained from a single level of non-vitros biorad lot 40450 quality control using vitros psa reagent lot 4610 tested on a vitros xt 7600 integrated system.The biorad results were lower than expected when compared to the customers baseline mean.The assignable cause of the event could not be determined.Historical quality control results indicated vitros psa reagent lot 4610 was not performing as intended within the timeframe of the event.Therefore, a vitros psa reagent related performance issue could not be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros psa reagent lot 4610.No diagnostic within-run precision testing was performed to assess the performance of the vitros xt 7600 integrated system; therefore, an instrument related performance issue cannot be completely ruled out as contributing to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros prostatic specific antigen (psa) results were obtained from a single level of non-vitros biorad lot 40450 quality control using vitros psa reagent lot 4610 tested on a vitros xt 7600 integrated system.The biorad results were lower than expected when compared to the customers baseline mean.Biorad level 3 vitros psa results of 10.679, 10.652, 10.469, 10.258, 10.475 and 10.745 ng/ml vs.The expected psa result of 14.35 ng/ml biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected results were obtained from non-patient quality control samples.The customer made no indication that patient samples were affected.There is no allegation of patient harm as a result of this event.This report is number two of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24404012
• Report Number: 3007111389-2026-00037
• Device Sequence Number: 9840036
• Product Code: LTJ
• UDI-Device Identifier: 10758750001309
• UDI-Public: (01)10758750001309(17)260219(11)250729(10)4610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 02/19/2026
• Device Catalogue Number: 6801756
• Device Lot Number: 4610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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