Z-2888-2026 Class II Ongoing
FDA device recall Z-2888-2026 was initiated by Beckman Coulter Inc. on June 26, 2026 and is designated Class II. Reason for recall: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." The recall status is ongoing. Affected quantity: 158 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- June 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158 instruments
Product Description
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
Reason for Recall
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
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.
Code Information
UDI: 15099590799243/ V5.03 Panel Update 11