FDA Device recall Z-1006-2025
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)…
- 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 XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)… by Ortho Clinical Diagnostics, citing the VITROS XT 7600 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1006-2025 |
| 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 XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (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 XT 7600 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.
Identifiers
| code_info | Lot Code: VITROS XT 7600 Integrated System Product Code: 6844461 (New) UDI: 10758750012343 VITROS XT 7600 System (Cert…Lot Code: VITROS XT 7600 Integrated System Product Code: 6844461 (New) UDI: 10758750012343 VITROS XT 7600 System (Certified) Product Code: 6272222 UDI: 10758750012343 Lot Code: VITROS XT 7600 Integrated System Product Code: 6904003 (China) UDI: 10758750035809 Range of installed serial numbers:76000001-76002199 Manufacture date range: July 2018 to present Distribution date range; July 2018 to present Total systems currently installed in the US: 994 Total systems currently installed outside the US: 899 Note1: The catalogue number 6844461 is used to denote the VITROS XT 7600 Integrated System. Catalogue number 6272222 is used to denote VITROS XT 7600 System Certified. A VITROS XT 7600 Integrated System maintains its original serial number through the 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 releas |
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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-1006-2025%22
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