Recall Z-0254-2018— Ortho-Clinical Diagnostics

Name: FDA recall Z-0254-2018
Creator: U.S. Food and Drug Administration
Published: 2017-04-26

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2017-04-26, terminated 2021-08-23. It names one FDA 510(k) clearance: K063144. Product: enGen Track System with TCAutomation Software Version 4.2. Reason: A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2017-04-26
Terminated: 2021-08-23
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc.·cleared 2006-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

enGen Track System with TCAutomation Software Version 4.2

Reason for recall

A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track

Data sourced from openFDA. This site is unofficial and independent of the FDA.