Ortho-Clinical recalls VITROS XT 7600 Integrated Systems with software versions 3.2 to 3.8.3 due to false expired reagent warnings that can cause inaccurate test results.
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Ortho-Clinical is recalling VITROS XT 7600 Integrated Systems with specific model numbers and software versions because a software issue causes the system to incorrectly flag reagent packs as expired even when they are not. This can lead to inaccurate test results or delays in processing tests.
The software anomaly causes the system to treat Micro Tip and Micro Slide diluent packs as expired even when they are not, if the shelf expiration date is omitted during manual loading. This happens when the 'Use Expired Reagents' setting is disabled, potentially leading to false 'Reagent Expired' codes and inaccurate test results.
Lab users with VITROS XT 7600 Integrated Systems (model numbers 6844461 and 6272222) that have software versions 3.2 through 3.8.3 are most at risk. These systems are used in clinical laboratories for diagnostic testing.
Check if your VITROS XT 7600 Integrated System has model numbers 6844461 or 6272222 and software versions 3.2 through 3.8.3. The system's serial numbers range from 76000109 to 76002327.
Verify your system's software version by checking the device settings or documentation.
Install the latest software update (version 3.8.3 or newer) to fix the issue.
The software error causes the system to incorrectly flag reagent packs as expired even when they are not, which can lead to inaccurate test results or delays in processing tests.
Your system is affected if it has model numbers 6844461 or 6272222 and software versions 3.2 through 3.8.3, with serial numbers between 76000109 and 76002327.
The official recall notice does not specify alternative actions if software updates are not possible.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2039-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2039-2025 from Ortho-Clinical. 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.
