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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that false reactive vitros ahbs results were obtained when an inhouse control fluid was processed using vitros ahbs lot 5215 in combination with two vitros eci immunodiagnostic systems as part of as part of internal post-expiry stability testing at ortho pencoed.A definitive cause of the event was not established.An issue isolated to the testing of the c-b11 in-house control cannot be ruled out as a contributor to the event.C-b11 results from vitros ahbs testing were acceptable on two other instruments.Additionally, vitros ahbs lot 5215 results from alternate in-house controls were acceptable and acceptable vitros ahbs lot 5215 results were obtained from selling controls.Furthermore, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahbs lot 5215.Instrument related issues are unlikely contributors to the event as false reactive vitros ahbs results were obtained on two different vitros eci immunodiagnostic system.In addition, the testing of alternate in-house controls and selling controls showed acceptable vitros ahbs performance on these instruments on the dates of testing.
Event or Problem Description
An ortho clinical diagnostics (ortho) quality engineer (qe) reported false reactive anti-hbs (ahbs) results when an in-house quality control (qc) was tested using vitros hepatitis b surface antigen (ahbs) lot 5215 on two vitros eci immunodiagnostic systems as part of stability testing.In-house control c-b11 results of 16.0 and 12.1 miu/ml (reactive) versus the expected result of 5.7 to 10.7 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The false reactive vitros ahbs results were obtained from a non-patient fluid as part of internal stability testing at ortho pencoed.There has been no 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).

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 22529868
• Report Number: 3007111389-2025-00089
• Device Sequence Number: 8028816
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: (01)10758750001682(17)250521(11)240924(10)5215
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 05/21/2025
• Device Catalogue Number: 6801925
• Device Lot Number: 5215
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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