FDA recall Z-3280-2018

Product

VITROS Sodium Slides, Catalog # 837 9034

Reason for recall

Potential for positively biased results

Distribution

US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands

Key facts

Status

Terminated

Initiation date

2018-05-05

Report date

2018-10-10

Termination date

2021-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3280-2018