Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0560-2024 — 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

U.S. FDA — Device Enforcement · Switzerland · 2023-11-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0560-2024
Date of alert: 2023-11-03
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Inpeco S.A.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07640172340004

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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