Reported Jul 9, 2025 · Ongoing
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software…
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 4600
- Chemistry System Model/Catalog Number
(1) 6802445(2) 6900440
- Software Versionversion 3.2 to version 3.8.3 (all available
- software versions) Product DescriptionIn vitro diagnostic chemistry analyzer
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Barcodes Product as published — VITROS 4600 Chemistry System 6802445— — 10758750012343UDI: 10758750012343 — VITROS 4600 Chemistry System - Refurbished 6900440— — 10758750033201UDI: 10758750033201 — Range of installed serial numbers:46000111-46001897 — Manufacture date range: April 2011 to present Distribution date range 6900440April 2011 to present Total systems currently installed in the US: 135 Total systems currently installed outside the US: 1,127 Total systems installed worldwide (Product Quantity Distributed): 1,262 Note1: The catalogue number 6802445 is used to denote the VITROS 4600 Chemistry System. is used to denote VITROS 4600 Chemistry System- refurbished. A VITROS 4600 Chemistry System maintains its original serial number through the refurbishment process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured, the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned. - Amount recalled
- 1262 units (135 US, 1127 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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