FDA Device recall Z-2039-2025
Brand Name: VITROS
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of Brand Name: VITROS by Ortho Clinical Diagnostics, citing a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2039-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-09 |
| Published | 2025-07-09 |
| 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: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
Reason
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Identifiers
| code_info | VITROS XT 7600 Integrated System; Product Code: 6844461; UDI: 10758750012343; VITROS XT 7600 System - Certified; Produ…VITROS XT 7600 Integrated System; Product Code: 6844461; UDI: 10758750012343; VITROS XT 7600 System - Certified; Product Code: 6272222; UDI: 10758750012343; Range of installed serial numbers:76000109-76002327; Total systems currently installed in the US: 1,019 Total systems currently installed outside the US: 939 Total systems installed worldwide (Product Quantity Distributed): 1,958 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 released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum a |
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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-2039-2025%22
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