Inpeco recalls Accelerator a3600 Automation Systems with Aliquoter Module (FLX-212) that may dilute samples during error handling, leading to 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 Accelerator a3600 Automation Systems with the Aliquoter Module (FLX-212) that may dilute samples during certain error conditions, causing inaccurate lab test results. This affects laboratory equipment used for sample processing.
When a clot detection error occurs during sample aspiration, the system may dispense the sample into a secondary tube that gets diluted with water from the hydraulic circuit. This dilution can cause inaccurate test results if the diluted sample is used for testing.
Laboratories using the Accelerator a3600 Automation System with Aliquoter Module (FLX-212) firmware versions AQMb_3-3-0.H86 or higher are affected. Lab technicians handling samples with this equipment are most at risk of inaccurate test results.
Check for the Aliquoter Module (Inpeco Part Number FLX-212) with firmware versions AQMb_3-3-0.H86 or higher, or the listed system serial numbers. The system is sold as the Accelerator a3600 or FlexLab.
Look for error messages indicating secondary sample tubes need manual management after clot detection errors.
Confirm the firmware version matches the affected versions listed in the recall notice.
The error occurs when a clot detection error is generated during sample aspiration, leading to potential sample dilution.
Check for the Aliquoter Module (Inpeco Part Number FLX-212) with firmware versions AQMb_3-3-0.H86 or higher, or the listed system serial numbers.
No, the recall does not require immediate stop use. Labs can continue using the equipment but should monitor for error messages and follow lab procedures.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-0433-2021 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-0433-2021 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.
