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	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that discordant vitros syphilis (syph) reactive results were obtained from three patient samples using two different vitros syph reagent lots tested on a vitros xt 7600 integrated system.The vitros syph reactive results were discordant when compared to negative results obtained from non-vitros syphilis methods.The results were obtained using vitros syph reagent lots 1760 and 1770.The assignable cause of the event could not be determined.A review of historical quality control results indicated vitros syph reagent lots 1760 and 1770 were performing as intended and did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros syph reagent lots 1760 and 1770.Although the customer did not process diagnostic precision testing on (b)(4), an issue with the analyzer is not a likely contributor to the event based on the historical quality control results.The customer did not provide any details concerning the pre-analytical centrifugation of the affected samples; therefore, it is unknown if the samples were centrifuged according to the sample collection device manufacturers specifications.Therefore, it is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Testing the same samples treated in a non-specific antibody blocking tube (nabt) determined the samples did not contain non-specific antibodies that could interfere with the vitros syph assay.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant vitros syphilis (syph) reactive results were obtained from three patient samples using two different vitros syph reagent lots tested on a vitros xt7600 integrated system.The vitros syph reactive results were discordant when compared to negative results obtained from non-vitros syphilis methods.The results were obtained using vitros syph reagent lots 1760 and 1770.Vitros syph reagent lot 1760 patient sample 1 vitros syph result of 3.305 s/c (reactive) versus the expected result of negative vitros syph reagent lot 1770 patient sample 4 vitros syph result of 3.204 s/c (reactive) versus the expected result of negative patient sample 5 vitros syph result of 1.302 s/c (reactive) versus the expected result of negative the discordant reactive vitros syphilis results had not been reported to a physician.There was no allegation of patient harm made as a result of the event.This report is number one 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 numbers (b)(4) and reportability assessment 613161.

• 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: 24225953
• Report Number: 3007111389-2026-00024
• Device Sequence Number: 18483325
• Product Code: LIP
• UDI-Device Identifier: 10758750035052
• UDI-Public: (01)10758750035052(17)260410(11)250425(10)1760
• 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): 01/29/2026

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: 04/10/2026
• Device Catalogue Number: 6177333
• Device Lot Number: 1760
• 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: 01/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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