FDA recall Z-2878-2020

Product

VITROS XT3400 Chemistry System, Product code 6844458

Reason for recall

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Key facts

Status

Terminated

Initiation date

2020-07-20

Report date

2020-09-02

Termination date

2023-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2878-2020