Ortho-Clinical recalls VITROS 3600 Immunodiagnostic Systems (new and refurbished) due to potential aspiration during sample processing, which may cause incorrect test results. Affected units have specific serial numbers and UDI/DI codes.
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Ortho-Clinical is recalling new and refurbished VITROS 3600 Immunodiagnostic Systems because a sample container might be aspirated during processing, leading to incorrect test results. This affects lab equipment used for medical testing.
During sample processing, the system could unintentionally aspirate a sample container. This might cause incorrect test results, which could affect patient care if the tests are used for critical medical decisions.
Healthcare facilities using the VITROS 3600 Immunodiagnostic System for medical testing are most affected. Lab technicians and medical staff who handle these systems may be impacted.
Check for serial numbers between J36001164 and J36001692 (inclusive) on the device. New units have UDI/DI code 10758750002979, refurbished units have 10758750007103.
Look for serial numbers between J36001164 and J36001692 on the device.
The system may unintentionally aspirate a sample container during processing, which can lead to incorrect test results.
Check the serial number: new units have J36001164 to J36001692, refurbished units have specific UDI/DI codes.
The recall does not specify a remedy, so contact Ortho-Clinical for guidance on next steps.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1220-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1220-2024 from Ortho-Clinical. 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.
