Z-0254-2018 Class II Terminated
FDA device recall Z-0254-2018 was initiated by Ortho-Clinical Diagnostics on April 26, 2017 and is designated Class II. 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 th… The recall status is terminated (terminated August 23, 2021). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2017
- Initiation Date
- April 26, 2017
- Termination Date
- August 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
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
Distribution Pattern
Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
Code Information
Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055