[Recalled] 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 diag
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Ortho-Clinical Diagnostics, INc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1005-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 December 2024 |
| EAN / barcode | 10758750002740 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Ortho-Clinical Diagnostics, INc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.