Ortho-Clinical recalls enGen Lab Automation Systems with software versions 4.6 and below due to risk of incorrect patient sample labeling, potentially leading to harmful medical interventions.
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 enGen Laboratory Automation Systems and enGen Track Systems with software versions 4:6 and below. This recall happens because a software issue could label samples incorrectly, which might lead to patients receiving wrong treatments and potential injury.
A software anomaly in the enGen system may cause samples to be labeled with the wrong patient information. This could lead to lab results being associated with the incorrect patient, potentially causing harmful medical interventions if the wrong patient receives treatment.
Healthcare facilities using enGen Lab Systems with software versions 4.6 and below are most at risk. Patients receiving lab tests through these systems could be affected if samples are mislabeled.
Check if your enGen Lab System has software version 4.6 or below. The product is used for in vitro clinical testing with VITROS Chemistry Products.
Verify your enGen system's software version to see if it is 4.6 or below.
Reach out to Ortho-Clinical Diagnostics for guidance on next steps.
Software versions 4.6 and below.
The recall states there is a risk of inappropriate medical interventions, which could lead to injury, but the exact risk level isn't specified.
Check if your enGen Lab System has software version 4.6 or below, as this product is used for in vitro clinical testing with VITROS Chemistry Products.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0800-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0800-2021 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.
