Inpeco Accelerator a3600 Aliquoter Module Recall for Sample Dilution Risk
Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples 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 is classified as FDA Class II. The hazard involves a risk of harm (erroneous test results) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Inpeco S.A. is recalling 136 units of the Accelerator a3600 Automation System equipped with the Aliquoter Module (Inpeco P/N FLX-212). The recall is triggered by a software defect in specific firmware versions that affects how the system handles samples when a Clot Detection Error occurs during aspiration from the Primary Sample Tube.
When this specific error is generated, the system dispenses the aspirated volume into the first empty Secondary Sample Tube. These tubes are flagged with error 2132 or 1442 and sent to IOM Priority Output Racks for manual management. The current error message advises operators to manage these tubes according to Laboratory Practice but fails to clarify that the samples may be diluted with water from the Aliquoter Module's hydraulic circuit. If these diluted samples are used for testing, it may lead to the reporting of erroneous results.
The affected units are distributed globally, including in the USA and numerous other countries. The impacted modules are identified by specific firmware versions (AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, AQMb_3-1-1-8.H86, and xAQMb_1-1-0.elf) and a list of specific System Serial Numbers. Users should verify their system serial numbers and firmware versions against the provided list to determine if their equipment is affected.
The recalled product
- Product
- Accelerator a3600 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 proc
- Manufacturer
- Inpeco S.A.
- Affected units
- 136
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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