Company:Sendx Medical Inc
Date of Enforcement Report 9/5/12
Class ll:
PRODUCT
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) – pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting. Z-2304-2012
REASON
The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient’s clinical condition.
RECALLING FIRM/MANUFACTURER
Sendx Medical Inc. Carlsbad CA on 6/6/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
ABL80 FLEX is 1680, ABL80 CO-OX is 1759
DISTRIBUTION
Nationwide
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