The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2198-2020·Announced 2020-06-10

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
71

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 3 products in this recall →

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