Company: Inpeco S.A.
Date of Enforcement Report 5/16/2018
Class II:

PRODUCT
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System Recall Number: Z-1798-2018

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/MANUFACTURER
Inpeco S.A. Lugano Switzerlandon 2/13/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
NY and IL

DISTRIBUTION
NY and IL