FDA-Device2022-01-05Class II
VIDAS Estradiol II, REF 30431-01
bioMerieux, Inc.
Hazard
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Sold states
US Nationwide distribution.
Affected count
One lot
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VIDAS Estradiol II, REF 30431-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0435-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief