Abaxis Inc: Medical Device Recall in 2020 - (Recall #: Z-2361-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 11, 2019

Date Posted: June 24, 2020

Recall Number: Z-2361-2020

Event ID: 85533

Reason for Recall:

Incorrect reference ranges of analytes.

Status: Terminated

Product Quantity: 15

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated