FDA recall Z-2361-2020
Abaxis Inc · Class II · device
Product
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Reason for recall
Incorrect reference ranges of analytes.
Distribution
All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
Key facts
- Status
- Terminated
- Initiation date
- 2019-12-11
- Report date
- 2020-06-24
- Termination date
- 2022-07-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Union City, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2361-2020