FDA recall Z-1609-2026

Beckman Coulter, Inc. · Class II · device

Product

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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 the likely presence of contamination in well(s).

Distribution

U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.

Key facts

Status
Ongoing
Initiation date
2025-07-24
Report date
2026-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2026