FDA-Device2020-06-10Class II
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Inpeco S.A.
Hazard
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
Sold states
US Nationwide distribution including in the states of IL, NY.
Affected count
71 systems
Manufactured in
Via San Gottardo 10, N/A, Lugano, N/A, Switzerland
Products
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2020Don't want to check this manually?
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