The Recall Desk
HighFDA (Devices)·Z-2115-2020·Announced 2020-06-03

Inpeco Accelerator a3600 Automation System Recalled for Safety Switch Delay

Inpeco S.A. is recalling two Accelerator a3600 Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

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: The recall involves a safety switch delay in a medical device, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Inpeco S.A. is recalling two units of the Accelerator a3600 Automation System. The recall involves specific modules, including High Volume Storage, HSQ Interface, Aliquoter, Rack Output, XN-9000 Interface, Advia 2120 LAS Interface, Vertical Transportation, Rack Input, AUWi System Interface, and Track To Rack Interface modules. The affected serial numbers are ACP.050 and ACP.146.

The recall is due to a defect in the sensors that activate the safety switches. In 1% of cases, the response delay for these sensors can be up to a maximum of 2 seconds, rather than the 40 milliseconds expected by design. This delayed activation may affect the system's safety performance.

The products were distributed to laboratories in Illinois and New York. Inpeco S.A. is the recalling firm. Consumers and facility operators should contact Inpeco S.A. for instructions on how to address the defect.

The recalled product

Product
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FL
Manufacturer
Inpeco S.A.
Affected units
2

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.050 ACP.146

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same hazard · safety switch delay

See all →