Ortho Clinical Diagnostics recalls VITROS XT 7600 software versions 3.5.1 and below due to potential reset of assay parameters. Affected units have serial numbers J76000111-J76000525.
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below. This could cause assay parameters to reset accidentally, potentially affecting test accuracy. Users should check their software version and serial number to see if they are affected.
The software may reset assay parameters to default settings under certain conditions. This could lead to inaccurate test results if the system is not properly configured after a reset. However, the risk is not severe enough to cause injury.
Users of the VITROS XT 7600 Integrated System with software versions 3.5.1 and below are affected. Laboratory personnel who perform tests using this equipment are most at risk.
Check if your VITROS XT 7600 system has software version 3.5.1 or below. Affected units have serial numbers starting with J76000111 and ending with J76000525.
Review your VITROS XT 7600 system's software version to see if it is 3.5.1 or below.
Confirm your system's serial number falls within the range J76000111-J76000525.
Software versions 3.5.1 and below are affected.
Check your software version and serial number. Affected units have software versions 3.5.1 or below and serial numbers J76000111-J76000525.
The recall does not specify a remedy, so you should contact Ortho Clinical Diagnostics for further instructions.
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-2484-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2484-2020 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.
