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

Recall Z-1359-2019 — ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitati

U.S. FDA — Device Enforcement · United States · 2019-04-09 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1359-2019
Date of alert: 2019-04-09
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Abbott Laboratories
Product category: device
Product type: Devices

Reported risk: Devices were delivered without the required dry ice.

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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