Ortho-Clinical recalls VITROS Automation Solutions (catalogs 6844300 & 6844301) due to software issues that may label samples incorrectly, risking wrong patient results and potential injury.
A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
Ortho-Clinical is recalling VITROS Automation Solutions with catalog numbers 6844300 and 6844301 because a software issue might label samples incorrectly, leading to wrong patient results and possible injury. This affects clinical lab equipment used for sample processing.
A software anomaly in versions 4.6 and below may cause the system to label a sample as the wrong patient. This could lead to incorrect lab results being associated with a patient, potentially causing inappropriate medical interventions and injury.
Clinical laboratory users who own or operate VITROS Automation Solutions with catalog numbers 6844300 or 6844301 are most at risk. The hazard primarily impacts patient safety through incorrect lab results.
Check if your VITROS Automation Solutions has catalog numbers 6844300 or 6844301. The product is used in clinical labs for automating sample processing and was sold with software versions 4.6 and below.
Verify your software version is 4.6 or below to confirm if the recalled model applies.
The recall is for a software issue that could lead to wrong patient results, but it does not cause immediate injury. The risk is low and depends on proper software use.
The recall does not specify a remedy, so contact Ortho-Clinical directly for guidance on next steps.
Check for catalog numbers 6844300 or 6844301 and software versions 4.6 or below.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0801-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0801-2021 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.
