The Recall Desk
HighFDA (Devices)·Z-1561-2023·Announced 2023-05-10

Laboratory Automation System Firmware May Misidentify Patient Samples

Inpeco laboratory automation systems' firmware can misassociate patient samples, potentially leading to incorrect electrolyte test results. The defect is rare but could cause serious medical consequences if results are misidentified or delayed.

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 device with risk of serious harm (cardiac arrhythmias, respiratory depression, potentially death) but no reported illnesses or injuries. Fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' The defect requires a rare, specific sequence of hardware and software failures to occur.

Plain-English summary

Inpeco S.A. is recalling the PVT Interface Module (PVT) firmware used in laboratory automation systems branded as FlexLab, Accelerator a3600, and Aptio Automation. The recall affects 245 units in the United States and thousands more distributed worldwide. Affected systems use part number 72747000.A and specific UDI codes for each brand variant.

The firmware can misassociate patient sample IDs with test orders in rare circumstances. The error occurs when a sample tube is released from the module at the same moment another tube fails to divert properly due to a malfunctioning divert gate. When this happens, one sample may be processed and reported under another sample's ID without triggering an error message, causing the system to lose sample traceability and process both samples according to incorrect test orders.

Abnormal electrolyte levels resulting from misidentified or delayed test results can cause serious medical consequences. Abnormal potassium levels can cause weakness, loss of kidney function control, intestinal paralysis, psychiatric disturbances, irregular heartbeat, respiratory depression, and death. Abnormal sodium levels can cause brain disturbances and water balance problems. Abnormal chloride levels can cause acid-base imbalances that may compromise breathing and heart function.

Inpeco has released a firmware update and Technical Service Bulletin with upgrade procedures. Field Service Engineers will perform the firmware upgrade on affected systems. Healthcare facilities using these systems should contact Inpeco to schedule the update.

The recalled product

Product
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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