Device product
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.
Z-0010-2019
Product summary
- Event
- Event 80718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,102
- Official record key
device-enforcement:Z-0010-2019
Official wording
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 information: ABL90 FLEX analyzers with software versions 3.3MR1 or below.
Distribution pattern: US Distribution and Internationally to Canada.
Derived failure modes
-
Unknown
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