FDA Device recall Z-1007-2025
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished),…
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished),… by Ortho Clinical Diagnostics, citing 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. T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1007-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-19 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | Lot Code: VITROS 3600 Immunodiagnostic System Product Code: 6802783 (New) UDI: 10758750002979 VITROS 3600 Immunodiagno…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 f |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1007-2025%22
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