The Recall Desk
HighFDA (Devices)·Z-1560-2023·Announced 2023-05-10

Laboratory Automation System Firmware May Misassociate Patient Samples

Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.

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: This is a FDA Class II medical device recall with no reported illnesses or injuries. However, the potential consequences are serious and explicitly documented—abnormal electrolyte levels can result in cardiac arrhythmias, respiratory depression, and death. The defect requires a specific rare timing scenario but could have critical clinical consequences if it occurs, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Inpeco is recalling Storage and Retrieval Module (SRM) Laboratory Automation systems sold under the brand names FlexLab, Accelerator a3600, and Aptio Automation. The systems have firmware versions that have the potential to mis-associate sample IDs, leading to incorrect or delayed results for sodium, potassium, and chloride testing.

The defect occurs when two rare conditions coincide: the module releases a sample tube just placed into the carrier while another sample tube fails to be properly diverted due to a divert gate malfunction. In this scenario, the first tube may be released as the second tube without any error message, causing the system to lose traceability of the original sample. Both tubes are then processed according to incorrect test orders.

Incorrectly reported electrolyte levels can lead to inappropriate medical treatment. Abnormal potassium levels can cause weakness, irregular heartbeat, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can cause central nervous system disturbances and water balance problems. Abnormal chloride levels can lead to acid-base imbalances affecting respiratory and cardiac function.

Affected units in the United States total 245 systems. The manufacturer has issued a Technical Service Bulletin with procedures for firmware updates to be performed by Field Service Engineers.

The recalled product

Product
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 F
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard
  • sample-misassociation
  • test-result-error
  • electrolyte-imbalance

Distribution

Distributed nationwide across the United States.

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