Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 1/13/2021
Class II
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).
Recall Number: Z-0800-2021
REASON
The firm confirmed a software anomaly that may have the potential for 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.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Inc. on 11/20/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
U.S. Nationwide and International