Inpeco Aptio Automation System Recall for Potential Sample Dilution
Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test 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 risk-of-harm product (medical device) where the defect can lead to erroneous test results, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Inpeco S.A. is recalling 104 units of the Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212). The recall affects specific firmware versions and system serial numbers listed in the agency's documentation. The systems are distributed globally, including in the United States and numerous other countries.
The recall is due to a software defect that occurs when a Clot Detection Error is generated during sample aspiration. In these instances, the aspirated volume is dispensed into the first empty Secondary Sample Tube. The system flags these tubes with error 2132 or 1442 and sends them to IOM Priority Output Racks for manual management. However, the current error message does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module.
If the diluted sample is used for testing, it may lead to the reporting of erroneous results. The source text does not report any illnesses, injuries, or deaths associated with this defect. Users should check their system serial numbers and firmware versions against the recall list and contact Inpeco S.A. for further instructions.
The recalled product
- Product
- Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in th
- Manufacturer
- Inpeco S.A.
- Affected units
- 104
Distribution
Distribution scope not specified by the agency.
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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