Company: Ortho-Clinical Diagnostics
Date of Enforcement Report 6/15/2016
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.. Recall Number Z-1914-2016
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
Ortho-Clinical Diagnostics, Rochester, NY on 4/6/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units
Nationwide and Internationally.