PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: January 13, 2021 Initiated: November 20, 2020 #Z-0800-2021

Product Description

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).

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.

Details

Units Affected
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.
Location
Rochester, NY

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 40 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0800-2021.

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