Inpeco recalls FlexLab and related lab automation systems due to firmware issues that may cause incorrect electrolyte test results, potentially leading to serious health risks if not addressed.
Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.
Inpeco is recalling its FlexLab laboratory automation systems because outdated firmware can misidentify sample tubes, leading to incorrect electrolyte test results. This could cause improper treatment or failure to treat abnormal results, risking serious health issues like cardiac problems or death.
The system may misidentify sample tubes during a specific brief window when releasing a tube, causing the wrong tube to be processed. This leads to incorrect electrolyte test results, which can cause serious health issues like cardiac arrhythmias or death if not corrected.
Lab technicians and healthcare facilities using Inpeco's FlexLab, Accelerator a3600, or Aptio Automation systems are most at risk. Patients receiving tests from these systems could experience incorrect electrolyte results.
Check for the product names FlexLab (FLX), Accelerator a3600 (ACP), or Aptio Automation (AP2). Look for part numbers starting with ACP-207, APT-207, FLX-207, or FLX-230. The system was sold with firmware versions that are not updated.
Inpeco field service engineers will update the firmware to correct the issue. Contact them directly for the update process.
The recall is due to firmware issues that can cause the system to misidentify sample tubes, leading to incorrect electrolyte test results which may result in serious health risks.
No, but you should contact Inpeco to update the firmware as soon as possible to prevent incorrect test results.
Incorrect electrolyte test results could lead to improper treatment or failure to treat abnormal results, potentially causing serious health issues like cardiac arrhythmias or death.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-1560-2023 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-1560-2023 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.
