Recall Z-1798-2018— Inpeco S.A.

Name: FDA recall Z-1798-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-13

Class II · Terminated

Class II FDA medical device recall by Inpeco S.A., initiated 2018-02-13, terminated 2019-04-03. It names one FDA 510(k) clearance: K121012. Product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System. Reason: Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients..

Recalling firm: Inpeco S.A.
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Terminated: 2019-04-03
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 (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

Reason for recall

Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.

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