MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS AMON SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	1726926
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that a lower-than-expected result was obtained from a single vitros liquid performance verifier (lpv) fluid using vitros ammonia (amon) slide lot: 1020-0267-3666 on a vitros 350 chemistry system.The assignable cause of the event was user error due to improper slide cartridge handling.The customer used a vitros amon cartridge where the on-board stability for a cartridge loaded on a vitros analyzer had been exceeded.Per the vitros amon instructions for use, the on-board stability for a vitros amon slide cartridge is
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected result from a single vitros liquid performance verifier (lpv) fluid using vitros ammonia (amon) slide lot: 1020-0267-3666 on a vitros 350 chemistry system.Vitros lpv ii, lot: m2779 vitros amon result of 150 umol/l vs.The expected result of 199.7 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected vitros amon result was obtained from a non-patient quality control fluid, however, the investigation could not rule out that patient sample results would not be affected if the event were to recur undetected.There was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• 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, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24575536
• Report Number: 1319809-2026-00021
• Device Sequence Number: 10475194
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)2601101(11)250503(10)102002673666
• 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): 03/11/2026

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: 1726926
• Device Lot Number: 1020-0267-3666
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• 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