FDA recall Z-3231-2026

Product

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Reason for recall

The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.

Distribution

International distribution to the countries of Austria, Germany, Luxembourg.

Key facts

Status

Ongoing

Initiation date

2026-07-24

Report date

2026-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3231-2026