Beckman Coulter Inc.: 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 Wa

Hazard

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Details from the source

Reason for recall: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." Distribution: 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. Quantity: 158 instruments Lot/code info: UDI: 15099590799243/ V5.03 Panel Update 11

UPC codes

15099590799243

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.