Reported Jul 9, 2025 · Ongoing
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- Brand NameVITROS
- Product NameVITROS 5600
- Integrated System Model/Catalog Number
(1) 6802413(2) 6802915
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published — VITROS 5600 Integrated System 6802413— — 10758750002740UDI: 10758750002740 — VITROS 5600 Integrated System - Certified/Refurbished 6802915— — 10758750002740UDI: 10758750002740 6802915Range of installed serial numbers: 56000143-56005096 Note1: The catalogue number 6802413 is used to denote the VITROS 5600 Integrated System. 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. - Amount recalled
- 3117 units (813 US, 2304 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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