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	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An ortho clinical diagnostics (ortho) field application specialist (fas) contacted the technical solutions center (tsc) on behalf of a customer to report a discordant, reactive vitros syph result obtained from a single patient sample when processed using vitros immunodiagnostic products syph tpa reagent lot 1850 on a vitros 5600 integrated system.The result was discordant when compared to the result from the same sample when tested using an alternate non-vitros abbott chemiluminescence method.Patient 1 sample results of 1.50 s/c (reactive) versus the expected result of 0.21 (negative) (abbott) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, false reactive vitros syph result was not reported from the laboratory.There has been no reported allegation 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).
Additional Manufacturer Narrative
The investigation has determined that a discordant, reactive vitros syph result was obtained from a single patient sample when processed using vitros immunodiagnostic products syph tpa reagent lot 1850 on a vitros 5600 integrated system.The result was discordant when compared to the result from the same sample when tested using an alternate non-vitros abbott chemiluminescence method.The assignable cause of this event is an interferent within the affected patient sample that affects the vitros method but not the non-vitros abbott method of testing.The other limitations section of the vitros syph instructions for use states the following: heterophilic antibodies in serum or plasma samples may cause interference in immunoassays.These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products.Results which are inconsistent with clinical observations indicate the need for additional testing.The customer processed the affected patient sample using a heterophilic block tube (hbt) collection device, which is designed to remove or neutralize potential interferents within a patient sample.The vitros syph result observed after the sample had been treated using the hbt was negative, indicating that a sample interferent was driving the discordant, reactive vitros syph result.Therefore, an interferent in the sample that affects the vitros syph method but not the non-vitros abbott method is the attributable cause of this event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros syph reagent lot 1850.

• 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: 25220112
• Report Number: 3007111389-2026-00104
• Device Sequence Number: 13206131
• Product Code: LIP
• UDI-Device Identifier: 10758750035052
• UDI-Public: (01)10758750035052(17)261013(11)251024(10)1850
• 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): 05/19/2026

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 Catalogue Number: 6177333
• Device Lot Number: 1850
• 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: 05/06/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• 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