Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software
Summary
The FDA issued a Class II for Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Nu by Ortho-Clinical Diagnostics, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2040-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
Lot/Code Info: VITROS 4600 Chemistry System; Product Code: 6802445; UDI: 10758750012343; VITROS 4600 Chemistry System - Refurbished; Product Code: 6900440; UDI: 10758750033201; Range of installed serial numbers:46000111-46001897; Manufacture date range: April 2011 to present Distribution date range; April 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. Catalogue number 6900440 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.
Quantity Affected: 1262 units (135 US, 1127 OUS)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-09
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2040-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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