Inpeco recalls Aptio Automation System with Aliquoter Module (FLX-212) due to clot detection errors causing diluted samples that may lead to incorrect test results. Affected units have specific serial numbers and firmware versions.
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Inpeco is recalling its Aptio Automation System with the Aliquoter Module (FLX-212) because a clot detection error can cause samples to be diluted with water from the hydraulic circuit. This may lead to incorrect test results if the diluted samples are used for testing.
When a clot detection error occurs during sample aspiration, the system dispenses the sample into a secondary tube that may be diluted with water from the hydraulic circuit. This dilution can cause inaccurate test results if the diluted sample is used for testing.
Laboratory users with the Aptio Automation System and Aliquoter Module (FLX-212) firmware versions listed in the recall. Most at risk are lab technicians handling samples with the affected units.
Check for the Aliquoter Module with Inpeco part number FLX-212 and firmware versions including AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, or xAQMb_1-1-0.elf. Affected units have specific system serial numbers listed in the recall.
Look for error messages 2132 or 1442 in the system logs to identify affected units.
The Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212).
Firmware versions including AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, AQMb_3-1-1-8.H86, and xAQMb_1-1-0.elf.
Check if your system has the Aliquoter Module with Inpeco part number FLX-212 and one of the affected firmware versions listed in the recall. Affected units have specific system serial numbers provided in the recall.
The recall does not specify a remedy, so you should check for error messages 2132 or 1442 and contact Inpeco for further guidance.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-0434-2021 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-0434-2021 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.
