FDA recall Z-2715-2026

Product

VITEK 2 AST-N447 TEST KIT Product reference 424620

Reason for recall

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Distribution

International distribution to the countries of Belgium and the Netherlands.

Key facts

Status

Ongoing

Initiation date

2026-06-04

Report date

2026-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2715-2026