FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Product Description
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Reason for Recall
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.
Details
- Recalling Firm
- Inpeco S.A.
- Units Affected
- 71 systems
- Distribution
- US Nationwide distribution including in the states of IL, NY.
- Location
- Lugano, N/A
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