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.
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, 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…
- Manufacturer
- Inpeco S.A.
- Affected units
- 70
Distribution
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.
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