FEI 2939693
Abaxis, Inc.
3240 WHIPPLE RD., UNION CITY, CA, US
MDR events157All time
Recalls4All time
Registered products28
Establishment typeManufactureManufacture Medical Device
Registered product codes
28 product codes
Recent MDR events
157 on file
- Piccolo Xpress Chemistry AnalyzerJul 31, 2026Malfunction2939693-2026-00018
- PICCOLO XPRESS CHEMISTRY ANALYZERJul 17, 2026Malfunction2939693-2026-00017
- PICCOLO XPRESS CHEMISTRY ANALYZERJun 26, 2026Malfunction2939693-2026-00016
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 29, 2026Malfunction2939693-2026-00015
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 22, 2026Malfunction2939693-2026-00013
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 22, 2026Malfunction2939693-2026-00014
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 19, 2026Malfunction2939693-2026-00012
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 14, 2026Malfunction2939693-2026-00008
- PICCOLO XPRESS CHEMISTRY ANALYZER, RECERTIFIEDMay 14, 2026Malfunction2939693-2026-00011
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 8, 2026Malfunction2939693-2026-00009
Recalls
4 on file
- TerminatedMar 16, 2010
Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
View FDA record ↗ - TerminatedSep 17, 2008
The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
View FDA record ↗ - TerminatedSep 17, 2008
The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
View FDA record ↗ - TerminatedUnknown
Incorrect reference ranges of analytes.
View FDA record ↗
Compliance history
Matched by FEI 2939693.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.