MAUDE Adverse Event Report: Abaxis, Inc. PICCOLO XPRESS CHEMISTRY ANALYZER

Catalog Number	1100-0000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction

• Brand Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Common Device Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Manufacturer (Section D): Abaxis, Inc.; 3240 whipple road; union city CA 94587 -121
• Manufacturer (Section G): Abaxis, Inc.; 3240 whipple road; union city CA 94587 -121
• Manufacturer Contact: david longwell ; 3240 whipple road; union city, CA 94587--121
• MDR Report Key: 50904118
• Report Number: 2939693-2026-00030
• Device Sequence Number: 6037798
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20251125Y
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K934592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1100-0000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown