17

Feb

2010

Cl Il Sendx Medical ABL 80 CO-OX System

0

Company:Sendx Medical Inc
Date of Enforcement Report 2/17/2010
Class:ll

PRODUCT
ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX System 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-0150-2010

REASON
A potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the sample printout. All measured values will report correctly, only the CO-OX derived parameters listed below are at risk of being reported incorrectly: HCT p50 p50(T) p50(st) pO2 (a)/FO2(I) pO2(a,T)/FO2(I) pO2 pO2(x,T) BO2 DO2 Qt VO2 FShunt FShunt (T) Q V(B) ctO2

RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad, CA, by letter September 20, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
317 units

DISTRIBUTION
OH, Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark

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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