Ortho-Clinical recalls VITROS 5600 Integrated Systems with model numbers 6802413 and 6802915 due to software error that may show expired reagents when none are expired, risking 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 5600 Integrated Systems with specific model numbers because a software issue can cause the system to incorrectly flag reagent packs as expired even when they are not. This may lead to inaccurate test results or delays in processing tests.
The software anomaly causes the system to report reagent 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 during testing.
Healthcare facilities using VITROS 5600 Integrated Systems with model numbers 6802413 or 6802915 are most at risk. The issue affects systems that process tests like urine tests where reagent expiration is critical.
Check for model numbers 6802413 (standard) or 6802915 (refurbished/certified) on the VITROS 5600 Integrated System. Systems with serial numbers between 56000143 and 56005096 are affected.
Identify the model number on your VITROS 5600 system to see if it is 6802413 or 6802915.
Confirm your system's serial number falls within the range 56000143 to 56005096.
A software issue causes the system to incorrectly flag reagent packs as expired even when they are not, potentially leading to inaccurate test results.
Check for model numbers 6802413 or 6802915 and a serial number between 56000143 and 56005096.
No action is needed if your system's model number and serial number do not match the affected range.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2038-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2038-2025 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.
