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

Recall Z-0195-2013 — ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurse

U.S. FDA — Device Enforcement · United States · 2010-01-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0195-2013
Date of alert: 2010-01-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sendx Medical Inc
Product category: device
Product type: Devices

Reported risk: The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.

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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