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Ortho-Clinical Diagnostics, Inc. recalls enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the i
Recalled January 13, 2021 · FDA recall Z-0800-2021 · Ortho-Clinical Diagnostics
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. · FDA Class II
Units
40 units
Sold at
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.
Description
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.
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).
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →