Reported Jan 29, 2025 · Ongoing
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415…
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. · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- Brand NameVITROS
- Product NameVITROS 5600
- Integrated System Model/Catalog Number
6802413 (New)6802415 (Certified/Refurbished)6904001 (China)
- Software Versionversion 3.8.0
- or higher Product DescriptionIn vitro diagnostic chemistry analyzer
- FDA 3 letter product codeJJE
- ComponentNo, not a component
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 68029151075875000274010758750002740Lot Code: VITROS 5600 Integrated System (New) Product Code: 6802413 UDI: 10758750002740 VITROS 5600 Integrated System (Certified/Refurbished) UDI: 10758750002740 680241510758750035786Lot Code: VITROS 5600 Integrated System (China) Product Code: 6904001 UDI: 10758750035786 Range of installed serial numbers: 56000015-56004962 Manufacture date range: August 2008 to present Distribution date range; August 2008 to present Total systems currently installed in the US: 905 Total systems currently installed outside the US:2344 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. 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
- 3,249 units (905 US, 2,344 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
This product could cause temporary or reversible health problems — stop using it.
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