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.
What this means for you
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.
- Affected units
- 61
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Inpeco S.A.
See all →- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
- HighLaboratory automation systems recalled over unevaluated sample integrity function
FDA (Devices) · 2025-10-15
- HighFlexLab X system recalled over unevaluated blood sample integrity function
FDA (Devices) · 2025-10-15
- ModerateRoche Cobas Interface Module Firmware May Cause Delayed Sample Processing
FDA (Devices) · 2023-12-27
Same hazard · sample dilution
See all →- ModerateAbbott Accelerator APS Aliquoter Module Recalled for Sample Dilution Risk
FDA (Devices) · 2020-06-10
- ModerateInpeco Accelerator a3600 Automation System Recalled for Sample Dilution Risk
FDA (Devices) · 2020-06-10
- HighInpeco FlexLab Augomation System Recalled for Potential Sample Dilution
FDA (Devices) · 2020-06-10
- ModerateEdwards Lifesciences Recalls Pressure Monitoring Sets with VAMP Plus System
FDA (Devices) · 2013-04-24