FDA recall Z-2451-2021

Product

Verigene EP Amplification Reagent Kit Test

Reason for recall

There is potential for false positive results.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.

Key facts

Status

Ongoing

Initiation date

2021-08-03

Report date

2021-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2021