Inpeco recalls Accelerator a3600 Automation Systems with Aliquoter Module (P/N FLX-212) due to clot detection errors causing sample dilution. Affected units have specific serial numbers.
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 Accelerator a3600 Automation Systems with the Aliquoter Module (P/N FLX-212) because a firmware error can cause samples to be diluted when a clot detection error occurs. This could lead to inaccurate test results if the system is used without proper correction.
When a clot detection error (error codes E0E0 or 13E0) occurs during sample aspiration, the system may return 2/3 of the sample volume to the primary tube. This dilution with distilled water from the hydraulic circuit can cause inaccurate test results.
Users of the Accelerator a3600 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 are most at risk of inaccurate test results.
Check if your Accelerator a3600 system has the Aliquoter Module (P/N FLX-212) and the specific serial numbers listed in the recall notice. The serial numbers start with ACP and follow the pattern shown in the record.
Verify your system'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 sample dilution when a clot detection error happens, leading to inaccurate test results.
Error codes E0E0 or 13E0 during sample aspiration indicate the clot detection error that may cause sample dilution.
The system may dilute the sample with distilled water from the hydraulic circuit, causing inaccurate test results if not corrected.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-2199-2020 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-2199-2020 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.
