Inpeco S.A.: 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 handli

Hazard

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

Details from the source

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. Quantity: 1 unit US: 14 units OUS Lot/code info: FlexLab UDI-DI:07640172340004 Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0 Serial Number US: FLX.0208 Serial Numbers OUS: Serial Number FLX.0116 FLX.0165 FLX.0178 FLX.067 FLX.0127 FLX.0128 FLX.0150 FLX.0154 FLX.012 FLX.0121 FLX.0132 FLX.031 FLX.048 FLX.049

UPC codes

07640172340004

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.