FDA-Device2020-06-24Class II

Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

Abaxis Inc
Hazard

Incorrect reference ranges of analytes.

Sold states
All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
Affected count
15
Manufactured in
3240 Whipple Rd, Union City, CA, United States
Products
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2361-2020

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