Recall Z-0587-2017— Inpeco S.A.

Name: FDA recall Z-0587-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-04

Class II · Terminated

Class II FDA medical device recall by Inpeco S.A., initiated 2016-10-04, terminated 2019-05-31. It names one FDA 510(k) clearance: K121012. Product: FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.. Reason: Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets..

Recalling firm: Inpeco S.A.
Classification: Class II
Status: Terminated
Initiated: 2016-10-04
Terminated: 2019-05-31
Firm location: Lugano, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K121012 — FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.·cleared 2012-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

Reason for recall

Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.

Data sourced from openFDA. This site is unofficial and independent of the FDA.