The Recall Desk
HighFDA (Devices)·Z-1563-2023·Announced 2023-05-10

Laboratory automation system firmware recalled for sample mis-identification

Inpeco is recalling Alinity h laboratory automation system firmware that may mis-identify samples, causing incorrect electrolyte test results that could lead to improper patient treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for serious patient harm including cardiac arrhythmias, respiratory depression, and death. No illnesses or injuries have been reported, and the hazardous condition requires specific simultaneous hardware and firmware failures occurring within a narrow timeframe.

Plain-English summary

Inpeco is recalling Alinity h Interface Module (HSQ) laboratory automation system firmware. The recall affects 245 units in the United States distributed across three product brands: FlexLab (16 systems), Accelerator a3600 (121 systems), and Aptio Automation (108 systems). The product is also distributed in numerous other countries worldwide.

The firmware defect can mis-associate sample tube identifiers, leading to incorrect test results or delayed measurement of sodium, potassium, and chloride patient results. The event requires specific simultaneous conditions within a narrow timeframe: a sample tube being released as a new tube enters the carrier, while another sample tube fails to be properly diverted due to a hardware malfunction. Under these conditions, a sample may be released under an incorrect identifier without any error message.

Falsely elevated or decreased electrolyte levels can result in inappropriate treatment of normal results or failure to treat abnormal results. Abnormal potassium levels may cause weakness, excessive urination, bowel paralysis, psychiatric disturbances, irregular heartbeats, breathing difficulty, and potentially death. Abnormal sodium levels can cause brain disturbances and water balance problems. Abnormal chloride levels can lead to acid-base imbalances that may compromise breathing and heart function.

Inpeco has released a Technical Service Bulletin with procedures to update the firmware, which will be installed by Field Service Engineers. The company has opened a corrective action investigation to identify the root cause and prevent recurrence.

The recalled product

Product
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation System
Hazard
  • sample-mis-identification
  • lab-result-error
  • electrolyte-measurement-error

Distribution

Distributed nationwide across the United States.

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