The Recall Desk
ModerateFDA (Devices)·Z-2142-2020·Announced 2020-06-03

Inpeco Aptio Automation System Recalled for Sample Association Error

Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a specific operational error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Inpeco S.A. is recalling 70 Aptio Automation Systems equipped with Advia2120LAS, ImmunoCAP 1000, or StaRRsed Interface Modules. The recall involves specific serial numbers distributed nationwide, including in Illinois and New York.

The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This issue can occur only when an Interface Module is put off-line after a carrier in its secondary lane is physically returned to the main track and then put back on-line when the carrier is used to transport another tube.

Healthcare facilities and laboratories should contact Inpeco S.A. for instructions on how to address the defect.

The recalled product

Product
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-A
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard
Affected units
70

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Inpeco S.A.

See all →

Same hazard · sample misidentification

See all →