Inpeco recalls FlexLab interface modules for Sysmex XN-9000/XN-9100 analyzers due to potential mis-association of sample IDs causing incorrect or delayed lab results. Affected units have specific serial numbers.
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Inpeco is recalling FlexLab interface modules for Sysmex XN-9000 and XN-9100 analyzers because outdated firmware might cause lab results to be incorrect or delayed. This affects laboratory equipment used for critical electrolyte tests like sodium, potassium, and chloride measurements.
The firmware in the interface modules may mis-associate sample IDs, which can lead to incorrect lab results or delayed testing. This could affect critical electrolyte measurements like sodium, potassium, and chloride levels used in diagnosing and treating diseases.
Laboratories using the FlexLab system with Sysmex XN-9000/XN-9100 analyzers are affected. The risk is highest for facilities that rely on these modules for critical electrolyte testing.
Check for FlexLab interface modules labeled FLX-290-10, FLX-290-20, or FLX-295-10. Affected units have specific serial numbers: US: FLX.0133, FLX.0181; OUS: FLX.0048, FLX.0049, FLX.0121, FLX.0155, FLX.0160, FLX.0200.
Verify if your FlexLab interface module has any of the listed serial numbers: US: FLX.0133, FLX.0181; OUS: FLX.0048, FLX.0049, FLX.0121, FLX.0155, FLX.0160, FLX.0200.
The firmware in the interface modules may mis-associate sample IDs, leading to incorrect or delayed lab results for critical electrolyte tests.
FlexLab interface modules with Sysmex XN-9000/XN-9100 analyzers: FLX-290-10, FLX-290-20, and FLX-295-10.
No action is required if your serial number is not on the list of affected units.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-2973-2020 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-2973-2020 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.
