Recall Z-0010-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Radiometer America Inc
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.
| Date | May 25, 2018 |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | The firm, Radiometer America, Inc., notified customers via letter dated 05/25/2015. The letter provided the following: Reason for recall, Affect product description and codes, Risk for the patient, What customers must do, Countermeasure provided by Radiometer, contact information and Response Form. The customers were instructed to do the following: 1. Inform users of the ABL90 FLEX analyzer that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. Follow the procedure described |
| Quantity | 12,102 |
| Distribution | US Distribution and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120197 | ABL90 FLEX Radiometer Medical Aps, Mar 19, 2012 |