Ortho-Clinical Diagnostics: Medical Device Recall in 2018 - (Recall #: Z-0079-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 15, 2018

Date Posted: October 17, 2018

Recall Number: Z-0079-2019

Event ID: 80959

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.

Status: Terminated

Product Quantity: U.S.= 1255 ex-U.S.= 1504

Code Information:

Serial Numbers : J56000024 through J56003300

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated