FDA recall Z-0436-2022

Product

VIDAS Lyme IgM II (LYM), REF 416436

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-09-22

Report date

2022-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0436-2022