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Use caution Medical device recall · FDA · Published November 20, 2020

Ortho-Clinical enGen Lab System: Software Error May Cause Wrong Patient Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0800-2021Medical deviceOrtho-Clinical ›
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Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/63826-ortho-clinical-engen-lab-system-software-error-may-cause-wrong.

Source Summary by GovInfoNow · govinfonow.com/recall/63826-ortho-clinical-engen-lab-system-software-error-may-cause-wrong · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0800-2021

Cite this page

“Ortho-Clinical enGen Lab System: Software Error May Cause Wrong Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63826-ortho-clinical-engen-lab-system-software-error-may-cause-wrong. Based on FDA recall #Z-0800-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2021%22&limit=1).

The FDA announced on 2020-11-20 that Ortho-Clinical Diagnostics, Inc. is recalling the enGen Laboratory Automation System and enGen Track System due to a software anomaly that may cause samples to be mislabeled. This error could lead to results being associated with the wrong patient sample and potentially result in inappropriate intervention with the potential for injury to the patient.

How to tell if you have it

  • Brand: Ortho-Clinical
  • Product: enGen Laboratory Automation System, enGen Track System
  • Catalog Number: ENGEN
  • Configuration: VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module
  • Software Versions: 4.6 and below
  • Units affected: 40 units

The hazard

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample, according to the FDA. 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.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Recent brand recalls include Ortho-Clinical LAC Slides Recall (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12). Other recent recalls of similar products include GE Medical Systems ECG Systems Software Error Risks Patient Data Mix-Up (2026-04-21), Philips IntraSight Plus Software Error May Cause Wrong Patient Diagnosis (2026-08-06), and Da Vinci Surgical System: Software Error May Cause Instrument Failure (2025-11-07).

How to tell if you have this one

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.

  • Brand
    Ortho-Clinical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.
Recall numberProduct, codes & lots
Z-0800-2021enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).; enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below
Z-0801-2021VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.; enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your enGen system's software version to see if it is 4.6 or below.

  2. Contact Manufacturer

    Reach out to Ortho-Clinical Diagnostics for guidance on next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Maryland, Massachusetts, North Carolina, Ohio, Texas, Vermont, Virginia.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Nov 20, 202012. FDA classified it Class II: Jan 7, 202123. Published in FDA’s Enforcement Report: Jan 13, 202134. FDA terminated the recall: Oct 24, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Could this cause serious injury?

The recall states there is a risk of inappropriate medical interventions, which could lead to injury, but the exact risk level isn't specified.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0800-2021 (November 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0800-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA