Inpeco S.A.: Medical Device Recall in 2023 - (Recall #: Z-0560-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 3, 2023

Date Posted: December 27, 2023

Recall Number: Z-0560-2024

Event ID: 93423

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.

Status: Ongoing

Product Quantity: 1 unit US: 14 units OUS

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated