FDA Device

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

Hazard

The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.

What You Should Do

Remedy

Radiometer sent a Field Safety Notice dated December 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. What you should do short term: " Please ensure that the operator always closes the inlet when prompted by the analyzer, as per the labeling. " In case the inlet, by mistake, is not closed as per the labeling, please ensure that the following is carried out before measuring a patient sample: " Close the inlet and wait for the analyzer to go to READY (approximately five minutes) " Open the inlet and then close again (to initiate a Rinse) " Wait for the analyzer to go to READY (approximately 1 minutes) " Please return the confirmation fax form no. 1 to your RADIOMETER representative when the above actions have been implemented Final Solution provided by RADIOMETER: A mechanism will be provided in an upgraded version of the analyzer software to eliminate the possibility of this error. The new software version will be installed by your local engineer when available. Customers were instructed to ensure that this letter is distributed to the final end-user. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, opt 4.

Products

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Brand
Radiometer America Inc
UPC
Model number 393-090 (instrument).  The affected analyzers are serial numbers 393-090R0027N001 to present.

Units Affected

5002 units