Ortho-Clinical recalls VITROS XT7600 Integrated Systems due to potential aspiration during sample processing, which may cause inaccurate test results. Affected units have specific serial numbers.
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 VITROS XT7600 Integrated Systems because a sample container might be aspirated during testing, leading to incorrect test results. This affects laboratory equipment used for medical testing.
During sample processing, the system might unintentionally aspirate a sample container. This can cause the system to produce incorrect test results, which could impact patient care if not addressed.
Laboratories using the VITROS XT7600 Integrated System are affected. Lab technicians and medical staff who handle these systems are most at risk of inaccurate test results.
Check for serial numbers between J76000109 and J76001913 inclusive. The system is sold under the brand Ortho-Clinical Diagnostics.
Verify your VITROS XT7600 system's serial number falls within J76000109 to J76001913.
The VITROS XT7600 Integrated System with serial numbers from J76000109 to J76001913.
The system may aspirate sample containers during processing, leading to inaccurate test results.
No immediate stop is required; the recall involves checking serial numbers and ensuring accurate testing.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1222-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1222-2024 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.
