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
