# FDA recall Z-0560-2024

> **Inpeco S.A.** · Class II · device recall initiated 2023-11-03.

## 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

- **Recall number:** Z-0560-2024
- **Recalling firm:** Inpeco S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-03
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lugano, N/A, Switzerland

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0560-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0560-2024. Source: US FDA. Licensed CC0.

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