- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Affected products (lot / model / serial)
- UDI: 15099590799250/ V5.03 Panel Update 11
- Distribution pattern
- US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY.
- Firm location
- Brea, CA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2889-2026
- Recall initiated
- June 26, 2026
- FDA classification date
- August 5, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99349
- Last updated on HTM Vibe
- August 18, 2026