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 Instru
Beckman Coulter Inc.
The hazard
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: 15099590799243/ V5.03 Panel Update 11UPC 15099590799243Would you have heard about this one?
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