Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 680241...
FDA Recall #Z-2038-2025 — Class II — May 9, 2025
Product Description
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Reason for Recall
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Recalling Firm
Ortho-Clinical Diagnostics, Inc. — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3117 units (813 US, 2304 OUS)
Distribution
Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
Code Information
VITROS 5600 Integrated System; Product Code: 6802413; UDI: 10758750002740; VITROS 5600 Integrated System - Certified/Refurbished; Product Code: 6802915; UDI: 10758750002740; Range of installed serial numbers: 56000143-56005096 Note1: The catalogue number 6802413 is used to denote the VITROS 5600 Integrated System. Catalogue number 6802915 is used to denote those VITROS 5600 Integrated Systems that have been refurbished, these systems can also be referred to as certified. A VITROS 5600 Integrated System maintains its original serial number through the refurbishment/certification process.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated