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

Recall Z-1102-2019 — Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. T

U.S. FDA — Device Enforcement · United States · 2018-07-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1102-2019
Date of alert: 2018-07-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Laboratories, Inc
Product category: device
Product type: Devices

Reported risk: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

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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