Z-0079-2019 Class II Terminated

Recalled by Ortho-Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
October 17, 2018
Initiation Date
August 15, 2018
Termination Date
January 10, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
U.S.= 1255 ex-U.S.= 1504

Product Description

VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413

Reason for Recall

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

Distribution Pattern

Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain

Code Information

Serial Numbers : J56000024 through J56003300