Company: Radiometer America Inc.
Date of Enforcement Report 2/9/2011
Class ll:
PRODUCT
ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood. Recall # Z-1011-2011.
REASON
Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample “fails” the next result will inherit the patient data from the previous result.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letters on November 16, 2010.
Manufactaurer:Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
432 units
DISTRIBUTION
Nationwide and Internationally
