FDA recall Z-1794-2026

Product

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Reason for recall

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Distribution

International distribution to the country of Poland.

Key facts

Status

Ongoing

Initiation date

2025-09-08

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2026