MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6801861
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that discordant, non-reactive (negative) vitros anti-hiv (ahiv) results were obtained from a single patient sample processed using vitros immunodiagnostic products anti-hiv 1+2 reagent lot 4450 on a vitros 3600 immunodiagnostic system.The results were considered discordant when compared to the results using a non-vitros abbott method and from an unknown confirmatory testing method obtained from the same sample.A definitive assignable cause of the event was not able to be determined with the information provided.As no quality control results for vitros ahiv lot 4450 were provided, a reagent related issue cannot be ruled out as a contributor of the event.No precision testing was performed on the vitros 3600 system to verify instrument performance.Therefore, an instrument related issue cannot be ruled out as a contributing factor of the event.Pre-analytical sample processing cannot be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer recommended centrifugation protocol and what type of sample tube was used for the affected sample.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.According to the vitros ahiv instructions for use (ifu): results from citrate plasma samples will be proportionally lower due to dilution by the liquid anti-coagulant.Additionally, it states edta plasma is not a recommended specimen type.The sample was sent out for confirmatory testing by the customer, and the results of the testing were obtained by the customer on 22 april 2026.The date the sample was sent out, the type of confirmatory testing and date the confirmatory testing was performed were not provided upon request.Additionally, it is unknown how the sample was stored when sent out for the testing as the customer stated that the sample had not been refrigerated or frozen.According to vitros ahiv ifu, serum and plasma samples may be stored for up to 5 days at 2-8 degrees celsius (36 - 46 degrees fahrenheit).Serum and plasma samples tested initially and after 4 weeks storage at -20 degrees celsius (36 - 46 degrees fahrenheit) showed no differences in clinical performance.A sample storage related issue or an issue related to the time between testing events cannot be ruled out as contributing factors of the event.No information on the medical diagnosis of the patient or any medications being administered to the patient were provided upon request.According to the vitros ahiv ifu, the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A negative test result does not exclude the possibility of exposure to or infection with hiv.Levels of hiv antibodies may be undetectable in the early stages of infection.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ahiv lot 4450.
Event or Problem Description
A customer contacted (b)(6) to report discordant, non-reactive (negative) vitros anti-hiv (ahiv) results obtained from a single patient sample processed using vitros immunodiagnostic products anti-hiv 1+2 reagent lot 4450 on a vitros 3600 immunodiagnostic system.The results were considered discordant when compared to the results using a non-vitros abbott method and from an unknown confirmatory testing method obtained from the same sample.Patient sample vitros results of non-reactive versus the expected result of reactive.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reactive vitros ahiv results were not reported from the laboratory.There have been no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 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: 25112115
• Report Number: 3007111389-2026-00092
• Device Sequence Number: 16022312
• Product Code: MZF
• UDI-Device Identifier: 10758750001521
• UDI-Public: (01)10758750001521(17)260903(11)251104(10)4450
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/07/2026

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: 09/03/2026
• Device Catalogue Number: 6801861
• Device Lot Number: 4450
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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