The Recall Desk
ModerateFDA (Devices)·Z-2141-2020·Announced 2020-06-03

Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect 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, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Inpeco S.A. is recalling three units of the Accelerator a3600 Automation System equipped with specific Interface Modules (Advia2120LAS, ImmunoCAP 1000, or StaRRsed). The affected serial numbers are ACP.290, ACP.343, and ACP.365. These systems were distributed nationwide in the United States, including in Illinois and New York.

The recall is due to a communication error between the firmware of the Interface Modules and the Automation software. This error can cause an erroneous association between the carrier and the sample tube. The issue occurs only when an Interface Module is taken offline after a carrier in its secondary lane is physically returned to the main track, and then put back online when that carrier is used to transport another tube.

The source text does not specify the required actions for consumers or healthcare facilities, nor does it report any illnesses or injuries. Users of these systems should refer to the official FDA recall notice for specific instructions on how to address the defect.

The recalled product

Product
Accelerator a3600 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) is a modular system designed to automate Pre-Analytical and Post-Analyt
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: ACP.290 ACP.343 ACP.365

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 →

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