Reported Jan 29, 2025 · Ongoing
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914…
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 3600 Immunodiagnostic
- System Model/Catalog Number
6802783 (New)6802914 (Certified/Refurbished)6904000 (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
- Lot CodeVITROS 3600
- Immunodiagnostic System Product Code6802783 (New)
- UDI10758750002979 VITROS 3600 Immunodiagnostic System (Certified/Refurbished)
- Product Code6802914
- UDI10758750002979 VITROS 3600 Immunodiagnostic
- System (China) Product Code6904000
- UDI10758750035779
- Range of installed serial numbers36000004-36001776
- Manufacture date range
June 2008 to present Distribution date rangeJune 2008 to present Total
- systems currently installed in the US99 Total systems
- currently installed outside the US882
- Note1The catalogue number 6802783 is used to denote the VITROS 3600 Immunodiagnostic System. Catalogue number 6802914 is used to denote the VITROS 3600 Immunodiagnostic System that have been refurbished, these systems can also be referred to as certified. A VITROS 3600 Immunodiagnostic System Certified/Refurbished maintains its original serial number through the refurbishment/certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined
- Note2When 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
- Note3The 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
- 981 units (99 US, 882 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 3600 Immunodiagnostic 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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