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

Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or cap — recall Z-1975-2012

U.S. FDA — Device Enforcement · United States · 2011-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1975-2012
Date of alert: 2011-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Point Of Care Inc.
Product category: device
Product type: Devices

Reported risk: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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