FDA Medical devices recall ·
VITROS Product Name: VITROS 5600 Integrated System Model recall
- Recall number
- Z-1005-2025
- Date
- (initiated December 19, 2024)
- Company / brand
- Ortho-Clinical Diagnostics, Inc.
513 Technology Blvd, Rochester, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,249 units (905 US, 2,344 OUS)
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: VITROS 5600 Integrated System (New) Product Code: 6802413 UDI: 10758750002740 VITROS 5600 Integrated System (Certified/Refurbished) Product Code: 6802915 UDI: 10758750002740 Lot 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. Catalogue number 6802415 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 tod
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1005-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.