FDA recall Z-0912-2018

Product

VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

Reason for recall

This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

Distribution

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

Key facts

Status

Terminated

Initiation date

2017-09-22

Report date

2018-03-14

Termination date

2020-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0912-2018