enGen Track System with TCAutomation Software Version 4.2
Reported: December 20, 2017 Initiated: April 26, 2017 #Z-0254-2018
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
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 16
- Distribution
- Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
enGen Track System with TCAutomation Software Version 4.2. Recalled by Ortho-Clinical Diagnostics. Units affected: 16.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2017. Severity: Moderate. Recall number: Z-0254-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11