10

Oct

2008

Cl Il Abaxix Inc. Piccolo Chemistry Analyzer

0

Company: Abaxis Inc.
Date of Enforcement Report 10/8/2008
Class:ll

PRODUCT
a) Piccolo Chemistry Analyzer software version 6.121. Model Number 400-1028 in
polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-
contained reagent disk, intended for use with the Piccolo and PiccoloXpress
chemistry analyzers, for in vitro qualitative determination., Recall # Z-2286-2008;
b) Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel, model
number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-
contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination, Recall # Z-2287-2008

REASON
The product will recover tCO2 at approximately 5-7 units high relative to 03-10.

RECALLING FIRM/MANUFACTURER
Abaxis, Inc., Union City, CA, by letter on April 21, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,130 kits

DISTRIBUTION
Nationwide and Internationally

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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