Inpeco recalls Aptio Automation System units with Aliquoter Module (P/N FLX-212) due to clot detection errors causing sample dilution with hydraulic water. Affected units have specific serial numbers listed in the recall.
In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
Inpeco is recalling certain Aptio Automation System units that use the Aliquoter Module (P/N FLX-212) because a firmware error can cause the system to dilute samples with distilled water from the hydraulic circuit. This could lead to inaccurate test results if the system is used without proper maintenance.
When a clot detection error occurs during sample aspiration, the system may dispense 2/3 of the sample back into the primary tube. This action mixes the sample with distilled water from the hydraulic circuit, diluting it and potentially causing inaccurate test results.
Users of the Aptio Automation System with the Aliquoter Module (P/N FLX-212) who have the listed serial numbers are affected. Laboratory technicians and medical professionals using these systems for sample testing are most at risk of inaccurate results.
Check if your Aptio Automation System uses the Aliquoter Module with the specific serial numbers listed in the recall (e.g., AP2.0005, AP2.0008, etc.). The product is used for consolidating multiple analytical instruments into a unified workstation.
Verify your unit's serial number against the list of affected units provided in the recall notice.
The recall occurs because certain firmware versions in the Aliquoter Module can cause the system to dilute samples with distilled water from the hydraulic circuit when a clot detection error happens during sample aspiration.
The recall notice does not specify a remedy, so you should check your serial number against the list provided and contact Inpeco for further instructions.
This issue could lead to inaccurate test results due to sample dilution with distilled water from the hydraulic circuit, potentially affecting the reliability of your testing.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-2200-2020 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-2200-2020 from Inpeco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
