Company: Radiometer America Inc.
Date of Enforcement Report 6/22/2011
Class ll:
PRODUCT
ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Recall # Z-2112-2011
REASON
The firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the cassette, this could lead to a clinically serious misinterpretation of the results and possible misdiagnosis and/or mal-therapy in the critical patient care setting.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, by letters on February 4, and on February 24th, 2011.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
533 units
DISTRIBUTION
Nationwide and Canada
