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

Recall Z-3237-2017 — AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

U.S. FDA — Device Enforcement · United States · 2017-09-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3237-2017
Date of alert
2017-09-07
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 recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kPa or 36.9  46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
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.

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