Ortho-Clinical Diagnostics recalls VITROS 5600 systems with refurbished software V3.3.2 or below due to luminometer malfunction that may prevent processing microwell assays. Affected units have specific serial numbers and were serviced with a luminometer replacement.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems with refurbished software version 3.3.2 or older. This software version may cause the luminometer to malfunction, preventing proper processing of certain lab tests. If you own this equipment, you should contact the manufacturer for details.
The luminometer malfunction can prevent the system from processing microwell assays correctly. This means certain lab tests might not run properly, potentially leading to inaccurate results. However, the issue only occurs after a luminometer replacement during service repairs.
Healthcare labs using the VITROS 5600 system with refurbished software V3.3.2 or below are affected. Lab technicians and clinical staff who operate these systems are most at risk of test errors.
Check if your VITROS 5600 system has software version 3.3.2 or older. Affected units were serviced with a luminometer replacement and have specific serial numbers starting with UDI: 10758750007110.
Verify your VITROS 5600 system's software version; affected units have version 3.3.2 or below.
Reach out to Ortho-Clinical Diagnostics for specific guidance on your unit's status and next steps.
The software version may cause the luminometer to malfunction, preventing proper processing of microwell assays.
No, the recall does not require immediate discontinuation of use. Affected units were serviced with a luminometer replacement during repairs.
Check for software version 3.3.2 or below and confirm if your system had a luminometer replaced during service repairs.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1288-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1288-2019 from Ortho-Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
