Beckman Coulter Inc.: REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoS
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Beckman Coulter Inc.
- Product
- 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 / hazard
- Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-06-26
- Code info
- UDI: 15099590799243/ V5.03 Panel Update 11
- Product quantity
- 158 instruments
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Brea
- State
- CA
- Country
- United States
- Event id
- 99349
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