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

Catalog Number	6801925
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined reproducible, discordant positive vitros ahbs results were obtained from a single patient sample tested on two different vitros xt7600 integrated systems using vitros ahbs reagent lot 5280.The vitros ahbs positive results generated from reagent lot 5280 were discordant when compared to anti-hbs negative results obtained from the same sample using two different non-vitros methods.The assignable cause of the event is most likely an unknown sample interferent that affects the vitros ahbs assays but not the non-vitros anti-hbs methods.Heterophilic antibody interference was not a cause of the event as the sample was treated with a heterophilic blocking tube (hbt) and a non-specific antibody blocking tube (nabt) and the vitros ahbs results obtained from the blocking tube fluids were similar to the results obtained from the untreated sample.A performance issue with vitros ahbs reagent lot 5280 did not likely contribute to the event as historical quality control results were acceptable, indicating vitros ahbs reagent lot 5280 was performing as intended.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros ahbs reagent lot 5280.The customer did not perform any diagnostic within-run precision testing to assess instrument function on either vitros xt7600 integrated systems, however, since the false positive vitros ahbs results were obtained on two different instruments, a performance issue with either vitros xt7600 integrated system did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible, discordant positive vitros ahbs results were obtained from a single patient sample tested on two different vitros xt7600 integrated systems using vitros ahbs reagent lot 5280.The vitros ahbs positive results generated from reagent lot 5280 were discordant when compared to anti-hbs negative results obtained from the same sample using two different non-vitros methods.Vitros ahbs positive results of 46 and 22 miu/ml (>12 is antibody pos) vs.The expected result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant positive vitros ahbs results were not reported from the laboratory and there was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4), and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS 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: 23821008
• Report Number: 3007111389-2025-00134
• Device Sequence Number: 21325681
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: (01)10758750001682(17)260127(11)250501(10)5280
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/16/2025

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: 01/27/2026
• Device Catalogue Number: 6801925
• Device Lot Number: 5280
• 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: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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