Inpeco FlexLab Augomation System Recalled for Potential Sample Dilution
Inpeco S.A. is recalling 71 FlexLab Augomation Systems because a firmware error may dilute primary sample tubes with distilled water, potentially causing discrepant patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to discrepant patient results, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Inpeco S.A. is recalling 71 FlexLab Augomation Systems using the Aliquoter Module (Inpeco P/N FLX-212). These systems consolidate multiple analytical instruments into a unified workstation. The recall is due to a potential for discrepant patient results caused by the dilution of the primary sample tube.
In certain firmware versions, if a Clot Detection error (error code E0E0 or 13E0) occurs during sample aspiration, the error recovery procedure dispenses two-thirds of the sample volume back into the Primary Tube. Field evidence indicates that this process may dilute the Primary Tube with distilled water from the hydraulic circuit of the Aliquoter Module.
The affected units were distributed nationwide in the US, including in Illinois and New York. Users should check their serial numbers against the provided list to determine if their system is affected.
The recalled product
- Product
- FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
- Manufacturer
- Inpeco S.A.
- Affected units
- 71
Distribution
Part of a larger recall action
This product is one of 3 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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