MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 4600 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802445
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected ammonia (amon) results were obtained from a vitros liquid performance verifier ii (lpvii) fluid processed using vitros chemistry products amon slides on a vitros 4600 chemistry system.The assignable cause of the lower than expected vitros amon result is an instrument issue, related to microslide incubator contamination.Historical results from the vitros lpv control fluids were imprecise, indicating that vitros amon lot 1023-0271-0638 was not performing as expected in combination with the vitros 4600 system.The customer confirmed that they use ammonia based cleansers in the laboratory to clean the countertops, approximately five feet from the vitros 4600 system.As per vitros 4600 reference guide, cleaning solutions: "warning: sodium hypochlorite solution, bleach, ammonia, any ammonia (chlorine) containing compound and any other oxidizing agents may be hazardous, may cause erroneous results, and may also corrode metal parts.Therefore, 70% isopropyl alcohol-in-water is recommended.Be sure to use no more than a 70% concentrated solution of isopropyl alcohol-in-water.It is critical that enough water be present to solubilize proteins.Therefore, it is not recommended that laboratories utilize cleaning solutions containing chlorine around their vitros analyzers." the tsc advised the customer to discontinue the use of the ammonia based cleaners within the laboratory and the customer agreed.An ortho field engineer (fe) performed actions on the vitros 4600 system which included cleaning all surfaces that interact with the slides and replacing all evaporation caps.The results of a post-service vitros amon within run precision test processed on the vitros 4600 system were within ortho acceptable guidelines, indicating that the instrument performance was returned to expectations following the actions performed by the ortho fe.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected ammonia (amon) results were obtained from a vitros liquid performance verifier ii (lpvii) fluid processed using vitros chemistry products amon slides on a vitros 4600 chemistry system.Vitros lpvii lot p3086 level 2 results of 157.65, 147.38, 155.91, 157.98, 123.94, 152.41, 158.82, 149.51, 145.62, 146.78 umol/l vs the expected result of 198.7 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 results were obtained when processing a control fluid.No results were reported out of the laboratory.There have been no allegations 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 614959.

• Brand Name: VITROS 4600 CHEMISTRY SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25600020
• Report Number: 1319681-2026-00046
• Device Sequence Number: 9922081
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 6802445
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown