Z-0800-2021Class II

enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN -

Name: Z-0800-2021 enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN -
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2020-11-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-11-20 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a... on 2020-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0800-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-20
Posted: 2021-01-07
Terminated: 2023-10-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen 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).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On November 20, 2020, the firm sent Urgent Product Correction Notification letters to affected customers to inform them of the issue. Customers were reminded to follow product labelling regarding removing all tubes before performing maintenance or initializing the Aliquoter & Labeller Module. There should never be sample tubes present when initializing the Aliquoter & Labeller module. The firm's release of TCA Software version 4.7 is the planned mitigation for this issue. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 40 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0800-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0801-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)