Ortho-Clinical Diagnostics recalls refurbished VITROS 3600 systems with software V3.3.2 or below (product code 6802914) due to possible luminometer malfunction causing inability to process microwell assays.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling refurbished VITROS 3600 Immunoassay 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.
The luminometer malfunction can prevent the system from correctly processing microwell assays, which are used for clinical testing. This could lead to inaccurate test results if the system fails to process samples properly.
Lab technicians and healthcare facilities using the recalled VITROS 3600 systems with specific software versions. Those who have had the luminometer replaced during service repairs are most at risk.
Check if your VITROS 3600 system has software version 3.3.2 or below (product code 6802914). The recall affects systems that had the luminometer replaced during a service repair. Serial numbers are listed in the UDI: 10758750007103.
Verify your VITROS 3600 system's software version; if it is 3.3.2 or below, it is affected.
Reach out to Ortho-Clinical Diagnostics for guidance on next steps after confirming the affected software version.
The recall is due to a potential luminometer malfunction that could prevent the system from processing microwell assays correctly.
Check if your system has software version 3.3.2 or below (product code 6802914) and contact Ortho-Clinical Diagnostics for guidance.
The official recall does not specify a fix; contacting the manufacturer is the next step.
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-1290-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1290-2019 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.
