Inpeco recalls FlexLab Augmentation System with Aliquoter Module (FLX-212) due to potential sample dilution causing inaccurate patient results. Affected units have specific serial numbers.
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. 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 FlexLab Augmentation Systems with the Aliquoter Module (model FLX-212) because certain firmware versions may cause the primary sample tube to be diluted with distilled water, leading to inaccurate patient test results. This could affect medical testing accuracy if the system is used without correction.
In certain firmware versions, if the system detects a clot during sample aspiration (error codes E0E0 or 13E0), it may return 2/3 of the sample volume to the primary tube. This action can dilute the sample with distilled water from the hydraulic circuit, causing inaccurate patient test results.
Healthcare facilities using the FlexLab Augmentation System with Aliquoter Module (model FLX-212) are likely affected. Patients receiving tests from these systems may be at risk of inaccurate results.
Check if your FlexLab Augmentation System has the Aliquoter Module (model FLX-212) with serial numbers listed in the recall: FLX.008, FLX.0105, FLX.0106, and other specific serial numbers provided in the recall notice.
Identify the serial number on your FlexLab Augmentation System to see if it matches the list of affected serial numbers provided in the recall.
The recall is due to a potential issue in certain firmware versions where the system may dilute the primary sample tube with distilled water during clot detection errors, leading to inaccurate patient test results.
Error codes E0E0 or 13E0 during sample aspiration can trigger the issue where the system returns 2/3 of the sample volume to the primary tube.
Check if your FlexLab Augmentation System has the Aliquoter Module (model FLX-212) with a serial number listed in the provided recall list, such as FLX.008 or FLX.0105.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-2198-2020 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-2198-2020 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.
