--- title: "Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Ca... — FDA record Z-1007-2025 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-1007-2025-brand-name-vitros-product-name-vitros-3600-immunodiagnostic-system-model-catalog-number-6802783-new/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Ce... — FDA record Z-1007-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Ortho-Clinical Diagnostics, INc. - **Quantity**: 981 units (99 US, 882 OUS) - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1007-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1007-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Lot Code: VITROS 3600 Immunodiagnostic System Product Code: 6802783 (New) UDI: 10758750002979 VITROS 3600 Immunodiagnostic System (Certified/Refurbished) Product Code: 6802914 UDI: 10758750002979 VITROS 3600 Immunodiagnostic System (China) Product Code: 6904000 UDI: 10758750035779 Range of installed serial numbers:36000004-36001776 Manufacture date range: June 2008 to present Distribution date range; June 2008 to present Total systems currently installed in the US: 99 Total systems currently installed outside the US: 882 Note1: The 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. 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. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the 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. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jan 29, 2025 - **Recall initiation date**: Dec 19, 2024 - **Center classification date**: Jan 21, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1007-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ortho-Clinical Diagnostics, Inc. records](https://isitonrecall.com/brand/ortho-clinical-diagnostics-inc/)