FDA Medical Device Recalls (openFDA)
Abaxis Inc: Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
- Recall number
- Z-2361-2020
- Recalling firm
- Abaxis Inc
- Product
- Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
- Status
- Terminated
- Initiated
- 2019-12-11
- Posted
- not on file
- Terminated
- 2022-07-22
- Reason
- Incorrect reference ranges of analytes.
- 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
- 15
- Distribution
- All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K934592"]
- PMA numbers
- not on file
- Product code
- JJG
- Firm FEI
- 2939693
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28