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

Recall Z-1075-2014 — pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

U.S. FDA — Device Enforcement · United States · 2013-07-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1075-2014
Date of alert: 2013-07-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Radiometer America Inc
Product category: device
Product type: Devices

Reported risk: RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

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.

Recall Z-1075-2014 — pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

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