FDA Device recall Z-1220-2024
VITROS 3600 Immunodiagnostic System (New and Refurbished)
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of VITROS 3600 Immunodiagnostic System (New and Refurbished) by Ortho Clinical Diagnostics, citing potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1220-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-22 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Reason
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Identifiers
| code_info | Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Ortho Clinical Diagnostics
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FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products Ca Slides
FDA Device · Class II · 2025-08-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products CHE Slides
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Softwar…
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
All Ortho Clinical Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2024%22
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