Ortho-Clinical Diagnostics: Medical Device Recall in 2017 - (Recall #: Z-0254-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

enGen Track System with TCAutomation Software Version 4.2

Product Classification:

Class II

Date Initiated: April 26, 2017

Date Posted: December 20, 2017

Recall Number: Z-0254-2018

Event ID: 77172

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

Status: Terminated

Product Quantity: 16

Code Information:

Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055

Distribution Pattern:

Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain

Voluntary or Mandated:

Voluntary: Firm initiated