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

Catalog Number	6802454
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a discordant, non-reactive (negative) vitros anti-hcv (ahcv) result was obtained from a non-vitros randox international quality assessment scheme (riqas) proficiency fluid using vitros immunodiagnostic products ahcv reagent on a vitros xt 7600 integrated system.The result was considered discordant when compared to the repeat reactive results from the same sample across two analyzers.A definitive assignable cause of the discordant, non-reactive (negative) result could not be determined with the information provided.A review of qc fluid performance on the vitros xt 7600 integrated system indicates acceptable performance; therefore, a vitros ahcv reagent lot: 5951 issue is not a likely contributor to the event.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros ahcv reagent lot: 5951.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros ahcv reagent lot: 5951.A vitros tsh diagnostic marker precision study was requested in order to assess the performance of the vitros xt 7600 integrated system but was not performed.Instead, a vitros tsh3 precision study was performed but could not be evaluated as the concentration of the fluid used was outside of the required specifications for assessment.Therefore, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.The customer processed the riqas proficiency sample that produced the discordant, non-reactive vitros ahcv result on an expired calibration curve and using suboptimal maintenance procedures.It is possible that these user errors contributed to the discordant, non-reactive result, however, this could not be confirmed.A riqas sample handling and/or storage related issue is not a likely contributor to the event as the ortho field application specialist (fas) confirmed that the customer was following all manufacturer recommendations for sample handling and storage.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, non-reactive (negative) vitros anti-hcv (ahcv) result was obtained from a non-vitros randox international quality assessment scheme (riqas) proficiency fluid using vitros immunodiagnostic products ahcv reagent on a vitros xt 7600 integrated system.The result was considered discordant when compared to the repeat reactive results from the same sample across two analyzers.Riqas proficiency sample result of 0.66 s/c (negative) versus the expected result of 1.18 s/c (reactive) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The discordant, non-reactive vitros ahcv result was observed using a non-patient fluid and was not reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV 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: 23848895
• Report Number: 3007111389-2025-00138
• Device Sequence Number: 9835563
• Product Code: MZO
• UDI-Device Identifier: 10758750002801
• UDI-Public: (01)10758750002801(17)260325(11)250807(10)5951
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 03/25/2026
• Device Catalogue Number: 6802454
• Device Lot Number: 5951
• 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: 11/28/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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