Z-0010-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- May 25, 2018
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,102
Product 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 for Recall
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
Distribution Pattern
US Distribution and Internationally to Canada.
Code Information
ABL90 FLEX analyzers with software versions 3.3MR1 or below.