Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System Software Versions 3.3.3 and below due to potential reset of assay parameters. Affected units have serial numbers J56000114-J56001879.
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and older. This could cause assay parameters to reset accidentally, potentially affecting test accuracy. Users should check their serial numbers to see if they are affected.
The software may reset assay parameters without warning in certain situations. This could lead to inaccurate test results if the system is not properly configured after a reset.
Users of the VITROS 5600 Integrated System with software versions 3.3.3 and below are affected. Laboratory personnel who perform tests with this equipment are most at risk.
Check if your VITROS 5600 system has software version 3.3.3 or older. Affected units have serial numbers starting with J56000114 and ending with J56001879.
Verify your VITROS 5600 system's software version to see if it is 3.3.3 or older.
Software versions 3.3.3 and below are affected.
Check your serial number; affected units have numbers from J56000114 to J56001879.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for guidance.
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-2482-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2482-2020 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.
