Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System with V3.4 or 3.4.1 software (product code 6844461) due to potential for incorrect test results. Affected units have serial numbers 76000108 through current.
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems with specific software versions because they might give wrong test results. This could lead to inaccurate medical diagnoses if the system is used without correction.
The system might dispense sample fluid to the wrong position on the MicroSlide, causing the test results to be incorrect. This could lead to misdiagnosis if the system is used without correction.
Healthcare facilities using the VITROS XT 7600 system with V3.4 or 3.4.1 software (product code 6844461) are likely affected. Laboratory staff and medical professionals who rely on this system for diagnostic testing are most at risk.
Check for the VITROS XT 7600 Integrated System with V3.4 or 3.4.1 software (product code 6844461). Affected units have serial numbers starting from 76000108 through current.
Verify the software version on your VITROS XT 7600 system; affected units have V3.4 or 3.4.1 software (product code 6844461).
V3.4 or 3.4.1 software (product code 6844461).
Check the serial number on your VITROS XT 7600 system; affected units have serial numbers starting from 76000108 through current.
No action is needed if your system has a different software version or a serial number outside the affected range.
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-1364-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1364-2019 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.
