05

Sep

2012

Cl ll ABL80 FLEX ABL80 FLEX CO-OX

0

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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