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

ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology. — recall Z-2202-2015

U.S. FDA — Device Enforcement · United States · 2015-06-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2202-2015
Date of alert
2015-06-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Reported risk: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.