Ortho-Clinical recalls VITROS 5600 Integrated 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 5600 Integrated Systems because a design flaw might cause sample containers to be aspirated during testing, leading to inaccurate test results. This affects laboratory equipment used for medical testing.
The system may unintentionally aspirate sample containers during processing, which can cause incorrect test results. This happens due to a design flaw in the sampling center component of the system.
Laboratories using the VITROS 5600 Integrated System for medical testing are most affected. The risk is low as it only impacts test accuracy, not immediate safety.
Check for the VITROS 5600 Integrated System with serial numbers listed in the recall notice. New units have UDI/DI code 10758750002740 and refurbished units have 10758750007110.
Verify if your system has a serial number from the list provided in the recall notice.
The VITROS 5600 system may aspirate sample containers during processing, leading to incorrect test results due to a design flaw.
Check your serial number against the list provided in the recall notice to see if it's affected.
No immediate safety risks; the hazard only affects test accuracy, not physical harm.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1221-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1221-2024 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.
