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

Recall Z-2974-2020 — Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analyti

U.S. FDA — Device Enforcement · Switzerland · 2020-08-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2974-2020
Date of alert: 2020-08-07
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Inpeco S.A.
Product category: device
Product type: Devices

Reported risk: Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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