FDA Enforcement
Class II
Terminated
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.
Recall: Z-0010-2019
·
Reported October 10, 2018
Enforcement
- Recall Number
- Z-0010-2019
- Event ID
- 80718
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Radiometer America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 10, 2018
- Initiation Date
- May 25, 2018
- Classification Date
- October 1, 2018
- Termination Date
- November 6, 2020
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232, United States
Description
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
Code Info
ABL90 FLEX analyzers with software versions 3.3MR1 or below.
Distribution
US Distribution and Internationally to Canada.
Quantity
12,102