Z-2361-2020Class II

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

Name: Z-2361-2020 Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Creator: Abaxis Inc
Published: 2019-12-11
License: https://open.fda.gov/license/

Abaxis Inc / initiated 2019-12-11 / Terminated / root cause: software

FDA source

Abaxis Inc began a recall of Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) on 2019-12-11. FDA classified it as Class II and gives the reason as "Incorrect reference ranges of analytes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2361-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-06-12
Terminated: 2022-07-22
Recalling firm: Abaxis Inc
Product: Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Product code: JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Reason for recall: Incorrect reference ranges of analytes.
Root cause tag: software
FDA root cause: Software design
Action: On January 9, 2020, the firm sent an "Urgent Medical Device Recall' to their customers, regarding the chemistry analyzer containing software versions software versions 2.1.55/3.1.3. 5. This software failure may cause the product to display the incorrect reference ranges for certain analytes when gender selection is not set on the device. Erroneous reference values may result in an incorrect diagnosis or treatment plan.The firm informed customers to immediately stop using the devices and return it to the firm. On January 21, 2020, the firm instructed their customers to check the enclosed list of affected analytes and their correct reference range values and informed them that the erroneous reference values may result in an incorrect diagnosis or treatment plan. The affected products are shipped between 11/29/19 and 12/3/19, as either a unit on loan or as a repair/service of unit. The firm instructed customers to immediately examine their inventory and quarantine the product subject to recall. The firm ceased further distribution or use of the product. The firm instructed to the customers that their Technical Support arranged for the product return to the firm and would provide the repaired or replacement at no cost. The firm provided the Technical Support number as 1-800-822-2947 for customers to contact them.
Quantity in commerce: 15
Distribution: All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2361-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2361-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-12

Product code JJG

K934592Class IEpoc 2000 Point-of-Care Analyzer and Epoc 5-Chemistry Reagent RotorAbaxis, Inc. / cleared 1994-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)