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

Catalog Number	6801428
Medical Device Problem Codes	False Positive Result (1227); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant reactive anti-hbc (ahbc) results were obtained when two different samples from the same patient were tested using vitros immunodiagnostic products anti-hbc (ahbc) reagent pack lot: 2910, on a vitros xt 7600 integrated system.The results were considered discordant when compared to a negative result obtained from a non-vitros abbott alinity method.The assignable cause of the false reactive ahbc results is heterophilic antibody interference.The customer treated the patient sample (sample 2) with a heterophilic interference blocking tube (hbt) and a non-specific antibody blocking tube (nabt).As per the manufacturers interpretation of results for hbt, "a hbt is used for investigation purposes only.If the hbt is used for a secondary confirmation assay, compare the results from the first assay (initial sample not treated with hbt) and the confirmation assay (second sample treated with hbt).If the assay result from the hbt treated sample is different from the assay result from the untreated sample, the difference is due to heterophilic interference".The interpretation of the vitros ahbc result obtained from testing the patient sample after treatment with the hbt confirms that a heterophilic interferent that affects the vitros ahbc method, and not the non-vitros abbot alinity method likely contributed to the event.Additionally, a reactive ahbc result with all other hbv markers testing negative does not indicate an active or past hepatitis b infection.When ahbc is the only positive marker, it is often due to non-specific reactivity or interference rather than true infection.As the other vitros hbv markers are negative, the vitros ahbc result is most likely a false positive result.Historical quality control results prior to the events fell in the appropriate vitros interpretation classification, indicating acceptable accuracy when using vitros ahbc reagent lot: 2910.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ahbc reagent lot: 2910.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant reactive anti-hbc (ahbc) results obtained when two different samples from the same patient were tested using vitros immunodiagnostic products anti-hbc (ahbc) reagent pack lot: 2910, on a vitros xt 7600 integrated system.The results were considered discordant when compared to a negative result obtained from a non-vitros abbott alinity method.Patient 1, sample 1 vitros ahbc result of 0.84 s/c (reactive) vs the non-vitros ahbc result of 0.47 s/c (non-reactive).Patient 1, sample 2 vitros ahbc result of 0.56 s/c (reactive) vs the non-vitros ahbc result of 0.47 s/c (non-reactive).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 ahbc results were not reported from the laboratory.Ortho has not been made aware of any 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).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC 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: 24712999
• Report Number: 3007111389-2026-00062
• Device Sequence Number: 6121172
• Product Code: LOM
• UDI-Device Identifier: 10758750001217
• UDI-Public: (01)10758750001217(17)260908(11)250923(10)2910
• 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): 03/25/2026

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: 09/08/2026
• Device Catalogue Number: 6801428
• Device Lot Number: 2910
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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