Inpeco recalls FlexLab, Accelerator a3600, and Aptio Automation systems due to firmware issues causing incorrect patient test results. Affected units include specific serial numbers and part numbers.
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
Inpeco is recalling FlexLab, Accelerator a3600, and Aptio Automation systems because outdated firmware may link test results to the wrong patient samples. This could lead to incorrect patient diagnoses if not fixed.
The firmware in the Automation System Interface Module may incorrectly match test results to the wrong patient sample ID. This could cause misdiagnosis if the system fails to properly track samples during testing.
Healthcare facilities using the affected models of Inpeco automation systems are most at risk. Patients could receive incorrect test results if the system misassociates samples.
Check if your system has the FlexLab (FLX) serial numbers listed above, or Accelerator a3600 (ACP) part number ACP.334, or Aptio Automation (AP2) part numbers starting with AP2.0002.
Identify if your system matches the FlexLab, Accelerator a3600, or Aptio Automation models listed in the recall notice.
The system might link test results to the wrong patient, potentially causing incorrect diagnoses.
Check your system's serial numbers or part numbers against the lists provided in the recall notice.
The recall notice does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-0087-2022 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-0087-2022 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.