FDA recall Z-2115-2020

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 FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system 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

The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.

Distribution

The products were distributed to the following US States: IL and NY.

Key facts

Status

Terminated

Initiation date

2020-04-07

Report date

2020-06-03

Termination date

2024-06-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lugano, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2020