Inpeco recalls FlexLab automation systems with Aliquoter Module (FLX-212) due to potential diluted samples causing inaccurate lab test results. Affected units have specific firmware versions and serial numbers.
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 FlexLab automation systems with the Aliquoter Module (FLX-212) because a technical error can cause samples to be diluted with water, leading to inaccurate lab test results. This affects specific firmware versions and serial numbers of the equipment.
When a clot detection error occurs during sample aspiration, the system may dispense diluted samples into secondary tubes. These diluted samples can then be used for testing, leading to incorrect lab results if not properly managed.
Laboratory users with the FlexLab system and Aliquoter Module (FLX-212) firmware versions listed in the recall. Lab technicians and researchers handling samples are most at risk of inaccurate test results.
Check for the FlexLab system with Aliquoter Module (Inpeco P/N FLX-212) and specific firmware versions: AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, AQMb_3-1-1-8.H86, or xAQMb_1-1-0.elf. Affected units have the listed serial numbers.
Review the firmware version on your FlexLab system to see if it matches the affected versions listed in the recall.
Confirm your system's serial number is in the list of affected serial numbers provided in the recall notice.
The recall mentions a 'Clot Detection Error' during sample aspiration that flags secondary sample tubes with error codes 2132 or 1442, which may lead to diluted samples being used for testing.
Check if your system has the Aliquoter Module (Inpeco P/N FLX-212) with firmware versions listed (AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, AQMb_3-1-1-8.H86, or xAQMb_1-1-0.elf) and a serial number from the provided list.
The recall does not specify a remedy, so you should check the firmware and serial number to confirm if your system is affected. If affected, 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-0432-2021 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-0432-2021 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.
