Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System software versions 3.3.3 and below due to potential reset of assay parameters. Affected units may require software updates to prevent inaccurate test results.
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 units with refurbished software versions 3.3.3 and below. This recall is needed because the software may reset assay parameters, leading to inaccurate test results if not properly maintained.
The software may reset assay parameters to default settings under certain conditions, which could cause test results to be inaccurate. This issue is specific to refurbished units with older software versions and does not involve physical hazards like fire or injury.
Laboratories using the VITROS 5600 Integrated System with refurbished software versions 3.3.3 and below are affected. Lab technicians and medical professionals who perform tests with these units are most at risk of inaccurate results.
Check for the product code 6802915 and serial numbers listed in the recall notice. Affected units have refurbished software versions 3.3.3 and below.
Verify the software version on your VITROS 5600 system to ensure it is not 3.3.3 or below.
Contact Ortho Clinical Diagnostics to update to a newer software version if your system is affected.
The software may reset assay parameters to default settings, causing inaccurate test results if not properly maintained.
No, but you should update the software to a newer version to prevent inaccurate test results.
Affected units have product code 6802915 with refurbished software versions 3.3.3 and below.
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-2483-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2483-2020 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.
