Ortho-Clinical Diagnostics recalls VITROS 3600 software versions 3.3.2 and below due to potential luminometer malfunction causing inability to process microwell assays. Affected units include specific product codes and serial numbers.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below. This software version may cause the luminometer to malfunction, preventing proper processing of certain lab tests. If you use this system for medical testing, it's important to address the issue to avoid test errors.
The recalled software versions 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 fix.
Healthcare facilities using the VITROS 3600 system with the recalled software versions are most at risk. This affects labs that rely on this specific software for in vitro testing.
Check if your VITROS 3600 system has software version 3.3.2 or below. Product code 6802783 and serial numbers starting with 36001160 or higher are affected.
Verify your VITROS 3600 software version; versions 3.3.2 and below are affected.
Install the latest software update to resolve the luminometer issue.
Software versions 3.3.2 and below are affected.
Check for product code 6802783 and serial numbers starting with 36001160 or higher.
The recall addresses potential test errors, not direct injury risks. The hazard is low risk.
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-1289-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1289-2019 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.
