FDA-Device2021-01-13Class II
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).
Ortho-Clinical Diagnostics, Inc.
Hazard
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.
Sold states
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.
Affected count
40 units
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0800-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief