FDA recall Z-2344-2018

Product

VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic

Reason for recall

There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.

Distribution

Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden

Key facts

Status

Terminated

Initiation date

2018-05-09

Report date

2018-07-11

Termination date

2020-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2344-2018