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

Recall Z-2003-2020 — Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in

U.S. FDA — Device Enforcement · Switzerland · 2020-04-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2003-2020
Date of alert: 2020-04-07
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Inpeco S.A.
Product category: device
Product type: Devices

Reported risk: When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

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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