Inpeco recalls FlexLab IOM systems with firmware versions prior to 2-3-0 on GWC boards and all versions on DDT boards due to potential misidentification of sample tubes, which could lead to incorrect electrolyte results and serious health risks.
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 FlexLab IOM laboratory automation systems with specific firmware versions that may misidentify sample tubes, causing incorrect electrolyte test results. This could lead to inappropriate treatment or failure to treat abnormal results, potentially causing serious health issues like cardiac arrhythmias or death.
The system may misidentify sample tubes during specific rapid sequences, causing one tube to be processed as another. This leads to incorrect electrolyte test results, which can cause serious health issues like cardiac arrhythmias or death if not corrected.
Laboratory users with FlexLab IOM systems (FLX-201) using firmware versions prior to 2-3-0 on GWC boards or all versions on DDT boards are affected. Patients receiving tests from these systems are at risk of incorrect electrolyte results.
Check for FlexLab IOM systems (FLX-201) with firmware versions prior to 2-3-0 on GWC boards or all versions on DDT boards. Part numbers include FLX-201-00, APT-201-00, and others listed in the recall notice.
Reach out to Inpeco for a firmware update through their technical service team.
Firmware versions prior to 2-3-0 on GWC boards and all versions on DDT boards.
Misidentified sample tubes can lead to incorrect electrolyte test results, potentially causing inappropriate treatment or failure to treat abnormal results, which may result in serious health issues like cardiac arrhythmias or death.
Yes, Inpeco has released a technical service bulletin with a procedure for firmware updates to be performed by field service engineers.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-1559-2023 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-1559-2023 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.
