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

Recall date

December 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2361-2020

FDA classification

Class II

Brand / firm

Abaxis Inc

Sold / distributed

All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.

Why it was recalled

Incorrect reference ranges of analytes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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