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

Catalog Number	6177333
Medical Device Problem Code	False Positive Result (1227)
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 determined that discordant, reactive syphilis (syph) results were obtained from samples from two different patients when tested using a vitros immunodiagnostics product syphilis tpa reagent, lot 1820 on two different vitros xt 7600 integrated systems.The results were considered discordant when compared to non-reactive results obtained from a non-vitros rapid plasma reagin (rpr) method and a non-vitros abbott alinity method from the same patient samples.A definitive assignable cause for the discordant reactive syph results could not be determined.Historical qc fluid performance indicates a vitros syph lot 1820 performance issue is not a likely contributor to the event.Additionally, there is also no indication of any instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, as diagnostic within run precision testing was not performed on the instruments, an instrument issue cannot be completely ruled out as contributing to the event.Pre-analytical sample processing cannot be ruled out as a contributing factor, as it was determined that the customer was not following the sample collection device manufacture recommendation for sample centrifugation.It is possible that an interferent affecting the vitros syphilis method, but not the non-vitros abbott alinity method, contributed to the reactive results observed.The vitros syphilis ifu states: "heterophilic antibodies in serum or plasma samples may cause interference in immunoassays.These antibodies may be present in samples from individuals regularly exposed to animals or treated with animal serum products.Results that are inconsistent with clinical observations indicate the need for additional testing." however, heterophilic blocking tube (hbt) testing was not performed on the patient samples; therefore, the presence of heterophilic antibody interference cannot be ruled out as a contributing factor to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros syph lot 1820.
Event or Problem Description
An ortho clinical diagnostics (ortho) field application specialist (fas) contacted the ortho technical solutions centre (tsc) on behalf of the customer to report discordant, reactive syphilis (syph) results obtained from samples from two different patients when tested using a vitros immunodiagnostics product syphilis tpa reagent, lot 1820 on two different vitros xt 7600 integrated systems.The results were considered discordant when compared to non-reactive results obtained from a non-vitros rapid plasma reagin (rpr) method and a non-vitros abbott alinity method from the same patient samples.Patient 1, syph results of 1.836 and 1.825 s/c (reactive) vs.The expected non-vitros abbott alinity result of 0.07 s/c (non-reactive).Patient 2, syph result of 1.940 s/c (reactive) vs.The expected non-vitros abbott alinity result of 0.05 s/c (non-reactive).Biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected.The discordant, reactive vitros syph results were not reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report is number one of two 3500a forms being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 614093.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SYPHILIS 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: 24926917
• Report Number: 3007111389-2026-00080
• Device Sequence Number: 10668063
• Product Code: LIP
• UDI-Device Identifier: 10758750035052
• UDI-Public: (01)10758750035052(17)260831(11)250911(10)1820
• 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): 04/17/2026

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: 08/31/2026
• Device Catalogue Number: 6177333
• Device Lot Number: 1820
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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