FDA recall Z-0560-2024

Product

Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0

Reason for recall

Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.

Distribution

Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN.

Key facts

Status

Ongoing

Initiation date

2023-11-03

Report date

2023-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lugano, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0560-2024