FDA recall Z-1798-2018

Inpeco S.A. · Class II · device

Product

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.

Distribution

Distributors in 2 states: NY and IL.

Key facts

Status: Terminated
Initiation date: 2018-02-13
Report date: 2018-05-16
Termination date: 2019-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lugano, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2018