Inpeco Accelerator a3600 Automation System Recalled for Sample Dilution Risk
Inpeco is recalling 97 Accelerator a3600 Automation Systems because a firmware error may dilute primary samples with distilled water during clot detection.
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, and the hazard involves sample dilution which is a quality control issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or procedural errors.
Plain-English summary
Inpeco S.A. is recalling 97 units of the Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212). The systems are used to consolidate multiple analytical instruments into a unified workstation. The recall involves specific serial numbers listed in the agency's structured data.
The recall is due to a firmware issue where the error recovery procedure for Clot Detection errors (error codes E0E0 or 13E0) may dispense two-thirds of the sample volume back into the Primary Tube. Field evidence indicates that this process can lead to the dilution of the Primary Tube with distilled water from the hydraulic circuit of the Aliquoter Module.
The affected units were distributed nationwide in the United States, including in the states of Illinois and New York. Users should contact Inpeco S.A. for instructions on how to address the firmware issue or replace the affected modules.
The recalled product
- Product
- Accelerator a3600 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
- 97
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.
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