VITROS 5600 Integrated System Product Code 6802413 and Refurbished… — Class II medical device recall Z-0545-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2023-12-20, distributed nationwide. During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software i
| Recall number | Z-0545-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2023-10-10 |
| Classified | 2023-12-13 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 176 units |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 10758750002740, 10758750007110 |
| Serial numbers | J56000102, J56000116, J56000161, J56000246, J56000252, J56000317, J56000418, J56000425, J56000468, J56000512, J56000533, J56000665, J56000671, J56000680, J56000719, J56000831, J56000836, J56000910, J56000929, J56000972, J56000980, J56000993, J56000994, J56001015, J56001097 and 148 more |
Product
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Reason for recall
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0545-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.