medical Class II Updated 2020-06-24

Abaxis Inc recalls Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Soft

Recalled Product

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

Hazard / Issue

Incorrect reference ranges of analytes.

Issued by

FDA

Affected States: TX, PA, FL, OK, KY, CA, VA
Lot/Code Info: Model Number: 1100-0000; 1100-0001; Software version 2.1.55 (NGA models )/3.1.35(Jen II models) Serial Numbers:0000000P23019, 0000000P02700 0000000P22997, 0000000P24435 0000000P05910 0000000P05380 0000000P08467 0000000P06595 0000000P07622 0000000P07988 0000000P04609 0000000P24721 0000000P24495 0000000P20399 0000000P20131 0000000P02755
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