The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2200-2020·Announced 2020-06-10

Inpeco Aptio Automation System Recall for Firmware Error Recovery Defect

Inpeco S.A. is recalling 61 Aptio Automation Systems because a firmware error recovery procedure may dilute primary sample tubes with distilled water.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential sample dilution which could affect analytical results, but there are no reports of direct patient injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Inpeco S.A. is recalling 61 Aptio Automation Systems using the Aliquoter Module (Inpeco P/N FLX-212). These systems are used to consolidate multiple analytical instruments into a unified workstation. The recall affects units distributed nationwide in the United States, including in Illinois and New York.

The recall is due to a defect in certain firmware versions. When a Clot Detection error (error code E0E0 or 13E0) occurs during sample aspiration, the current error recovery procedure dispenses two-thirds of the sample volume back into the Primary Tube. Field evidence indicates that this procedure may lead to the dilution of the Primary Tube with the distilled water from the hydraulic circuit of the Aliquoter Module.

Users of the affected systems should contact Inpeco S.A. for further instructions on how to address the firmware issue. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

Product
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard
Affected units
61

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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