Inpeco recalls Alinity h Interface Module (HSQ) lab automation systems due to potential mis-association of sample IDs causing incorrect electrolyte results. This could lead to improper treatment or serious health risks if not corrected.
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 Alinity h Interface Module (HSQ) lab automation systems because firmware issues might mix up sample IDs, leading to incorrect electrolyte test results. This could cause improper treatment or serious health risks like cardiac issues or death if not fixed.
The firmware may misidentify sample tubes during a specific brief moment when the system releases one tube but incorrectly associates it with another. This causes incorrect test results for electrolytes, which can lead to serious health issues like cardiac arrhythmias or death if not addressed.
Laboratory users with the Alinity h Interface Module (HSQ) system, particularly those handling blood tests for electrolytes like potassium, sodium, and chloride. Patients with abnormal electrolyte levels are at higher risk of complications.
Check for the Alinity h Interface Module (HSQ) system with brand names FlexLab (FLX), Accelerator a3600 (ACP), or Aptio Automation (AP2). The part numbers are FLX-274-20, UDI: FlexLab 07640172340004, Accelerator a3600 07640172341001, or Aptio Automation 07640172342008. All firmware versions are affected.
Inpeco will send Field Service Engineers to update the firmware on your device. This fix requires professional installation.
The firmware may misidentify sample tubes during a specific brief moment, causing incorrect electrolyte test results which could lead to serious health risks if not corrected.
Check for the Alinity h Interface Module (HSQ) system with brand names FlexLab (FLX), Accelerator a3600 (ACP), or Aptio Automation (AP2). The part numbers are FLX-274-20, UDI: FlexLab 07640172340004, Accelerator a3600 07640172341001, or Aptio Automation 07640172342008. All firmware versions are affected.
No. The device can continue to be used safely with a firmware update from Inpeco's 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-1563-2023 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-1563-2023 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.
