Ortho-Clinical Diagnostics recalls VITROS 5600 systems with software V3.3.2 or below (product code 6802413) due to possible luminometer malfunction causing inability to process microwell assays. Affected units include serial numbers 56003270 and above with UDI 10758750002740.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems with 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, it's important to check your software version and contact the manufacturer for guidance.
The software version 3.3.2 and below may cause the luminometer to malfunction, which can prevent the system from properly processing microwell assays. This could lead to inaccurate test results if the system is used without the proper software update.
Healthcare facilities and labs using the VITROS 5600 system with software version 3.3.2 or below are most at risk. Affected units have serial numbers 56003270 and above with UDI 10758750002740.
Check your VITROS 5600 system's software version. If it's 3.3.2 or below, it's affected. Affected units have serial numbers 56003270 and above with UDI 10758750002740.
Verify your VITROS 5600 system's software version; if it's 3.3.2 or below, it's affected.
Software versions 3.3.2 and below are affected.
Check your system's serial number (56003270 and above) and UDI (10758750002740).
No, but you should check your software version and contact Ortho-Clinical Diagnostics for guidance.
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-1287-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1287-2019 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.
