Radiometer America, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 1 Recalls: 2

Known Identifiers & Locations

FEI Numbers 1523456, 3010420736
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K944753 SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP 1995-02-24 Substantially Equivalent View Details

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0010-2019 ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting. Reason: The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again 2018-05-25 Terminated View Details
Z-0038-2008 Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers. Reason: Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use. 2007-06-22 Terminated View Details

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