Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System (Product Code 6844461) due to software error that may cause incorrect test results without error alerts. Affected units run software versions 3.4 or 3.4.1.
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
Ortho-Clinical Diagnostics is recalling its VITROS XT 7600 Integrated System because a software error could cause incorrect test results without warning. This affects laboratory equipment that uses specific reagents and runs software versions 3.4 or 3.4.1. Using this system without fixing the issue might lead to inaccurate medical testing.
The software algorithm that detects sample dispensing errors was disabled, so the system might report incorrect test results without showing an error message. This could lead to inaccurate medical diagnoses if the system is used without warning.
Laboratories using the VITROS XT 7600 Integrated System with software versions 3.4 or 3.4.1 are most at risk. This affects medical testing equipment used in clinical labs for diagnostic purposes.
Check for the product code 6844461 and unique device identifier 1075870031658. The system must run software versions 3.4 or 3.4.1 to be affected.
Contact Ortho-Clinical Diagnostics to get the corrected software version 3.4.2 or later.
A software algorithm that detects sample dispensing errors was inadvertently disabled, which may cause incorrect results without error alerts.
Software versions 3.4 and 3.4.1.
Look for product code 6844461 and unique device identifier 1075870031658. Affected systems run software versions 3.4 or 3.4.1.
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-1222-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1222-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
