The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2140-2020·Announced 2020-06-03

Inpeco FlexLab Automation System Recalled for Sample Association Errors

Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 hazard involves a specific operational error leading to sample misassociation without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Inpeco S.A. is recalling 37 FlexLab Automation Systems equipped with specific Interface Modules (Advia2120LAS, ImmunoCAP 1000, or StaRRsed). The recall affects systems distributed nationwide, including in Illinois and New York. The identified issue is an erroneous association between the carrier and the sample tube, caused by a communication error between the Interface Modules' firmware and the Automation software.

This problem occurs only under specific conditions: when an Interface Module is taken off-line after a carrier in its secondary lane is physically returned to the main track, and then put back on-line while that carrier is used to transport another tube. This can lead to incorrect sample handling in the laboratory.

Healthcare facilities and laboratories should contact Inpeco S.A. for instructions on how to resolve the issue. The recall is limited to the 37 systems with the specific serial numbers listed in the agency's documentation.

The recalled product

Product
FlexLab 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-Analytical…
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard
Affected units
37

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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