FDA recall Z-0080-2019

Product

VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915

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

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

Key facts

Status

Terminated

Initiation date

2018-08-15

Report date

2018-10-17

Termination date

2022-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2019