Piccolo Xpress 1100-0000Recalls & reported problems
Abaxis, Inc. · The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests. Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Abaxis Piccolo Xpress is a small portable blood chemistry analyzer used for on-site testing with single-use reagent discs. The 39 reports mostly describe results reading higher or lower than expected — such as sodium and potassium values — along with odor or smoke coming from the device and software or temperature errors. No deaths and no injuries were reported. There are no recalls naming this device, and all reports came in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI EABA110000001), received between Jan 2, 2020 and Sep 29, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Smoking” (10 reports).
1 other recall cover devices cleared under the same FDA submission (K934592); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Smoking10
- Device Emits Odor9
- High Test Results8
- Low Test Results4
- Computer Software Problem3
- High Readings2
- Output Problem2
- Temperature Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient16
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935978 ↗MalfunctionSep 25, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905981 ↗MalfunctionSep 25, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904118 ↗MalfunctionSep 17, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812362 ↗MalfunctionMay 29, 2026Low Test Results
ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION. A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY LOW POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND PICCOLO XPRESS ANALYZER AND COMPREHENSIVE METABOLIC PANEL (CMP) LOT# 6022AC3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332302 ↗MalfunctionMay 14, 2026High Test Results
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO BASIC METABOLIC PANEL, LOT#5463AB4. ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION
Patient problems: Insufficient Information
MAUDE report 25167317 ↗MalfunctionMay 14, 2026High Test Results
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION CHEM K+ / K+ PROBLEM OR QUESTION.
Patient problems: Insufficient Information
MAUDE report 25167104 ↗MalfunctionMay 8, 2026Low Test Results
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY LOW POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO RENAL PANEL, LOT#5401DA1. THE PATIENT WAS NOT TREATED ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129199 ↗MalfunctionMay 1, 2026High Test Results
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTED HIGH-TEST RESULT ON SODIUM (NA+) AND CHLORIDE (CL) USING THE PICCOLO XPRESS ANALYZER, SERIAL NUMBER (B)(6) AND THE COMPREHENSIVE METABOLIC PANEL (CMP) LOT 5493AC6. THE PATIENT WAS NOT TREATED ERROR CODES: CHEM NA+ / NA+ PROBLEM OR QUESTION. CHEM CL/ CL PROBLEM OR QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062166 ↗MalfunctionApr 24, 2026High Test Results
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO BASIC METABOLIC PANEL. CHEM HIGH/LOW: HIGH. CHEM K+ / K+ PROBLEM OR QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24985901 ↗MalfunctionFeb 27, 2026High Test Results
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL, LOT 5304BC4. THE PATIENT WAS TREATED. CHEM HIGH/LOW: HIGH. ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475271 ↗MalfunctionDec 8, 2025Low Readings; Low Readings
10NOV2025: ZOETIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A HEALTHCARE PROFESSIONAL REPORTING AN UNEXPECTED LOW POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER, SERIAL NUMBER (B)(6), AND THE PICCOLO BASIC METABOLIC PANEL (BMP), LOTS 5235AA3,5182AB1, AND PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 5301BC0.THE PATIENT WAS TREATED. THE CUSTOMER EXPRESSED CONCERN ABOUT THE ACCURACY OF THE PICCOLO XPRESS ANALYZER SN (B)(6) AFTER COMPARING POTASSIUM (K+) RESULTS FROM THE SAME SAMPLE RUN ON THEIR SECOND PICCOLO XPRESS ANALYZER (B)(6) USING THE PICCOLO CMP PANEL, LOT 5301BC01. THE EXPECTATION WAS THAT BOTH THE BMP PANEL AND THE COMPARISON CMP PANEL WOULD YIELD SIMILAR POTASSIUM RESULTS. CHEM HIGH/LOW: LOW ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.
Patient problems: Insufficient Information
MAUDE report 23746610 ↗MalfunctionOct 6, 2023Computer Software Problem; Operating System Version or Upgrade Problem; Computer Software Problem; Operating System Version or Upgrade Problem
A PREVIOUS VERSION OF COMBINED SOFTWARE FOUND ON THE PICCOLO XPRESS CHEMISTRY ANALYZER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17885667 ↗MalfunctionMar 15, 2023Output Problem; Output Problem
A LABORATORY HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED HIGH POTASSIUM (K+) RESULTS. INVOLVING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(4) USING THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 2417BB0. THE PATIENT WAS TREATED BASED ON THE RESULTS OF THE PICCOLO XPRESS CHEMISTRY ANALYZER RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16548227 ↗MalfunctionNov 4, 2022High Readings; High Readings
A LABORATORY HEALTH PROFESSIONAL REPORTED THEY WERE ABLE TO HARMONIZE PICCOLO XPRESS ANALYZER RESULTS ACROSS ALL OF THEIR INSTRUMENTS (ARCTIIC C8000, ISTAT, ARCHITECT) WITH THE EXCEPTION OF POTASSIUM. WHEN AN ANALYZER'S VALUE IS ABOVE THE UPPER REFERENCE LIMIT, THE ORDERING PHYSICIAN REQUESTS THE SPECIMEN ANALYSIS BE REPEATED ON A DIFFERENT ANALYZER. WHEN THE REPEATED RESULTS ARE LOWER THAN THE PREVIOUS ANALYZER'S VALUE, IT HAS AN EFFECT ON THE PHYSICIAN'S DECISION-MAKING AND ON THE PHYSICIAN'S CONFIDENCE IN THE LAB. THE CLINIC PROCESSES SPECIMENS FOR CANCER PATIENTS. DUE TO THE REPEAT SPECIMEN ANALYSIS, THE CLINIC EXPRESSED CONCERN WITH PATIENT CARE DUE TO THE AMOUNT OF TIME TO GET REPEAT RESULTS BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15735885 ↗MalfunctionSep 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Output Problem
THE CUSTOMER A HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED HIGH POTASSIUM (K+) ON THE XPRESS PICCOLO ANALZYER. THE PATIENT WAS NOT TREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15390355 ↗MalfunctionApr 15, 2022Low Test Results; Low Test Results
THE HEALTH PROFESSIONAL REPORTED UNEXPECTED LOW POTASSIUM RESULTS ON MULTIPLE BLOOD DRAWS. THE PATIENT WAS TREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14118662 ↗MalfunctionApr 28, 2021Smoking; Smoking
THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A 430B SPINDLE MOTOR ERROR AND EMITTED SMOKE WHEN POWERED ON. NO FIRE OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737973 ↗MalfunctionApr 16, 2021Device Emits Odor; Device Emits Odor
THE CUSTOMER REPORTED THAT THE DEVICE EMITTED A BURNING-LIKE SMELL AND WAS DISPLAYING A "CRITICAL STOP" ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11680493 ↗MalfunctionApr 9, 2021Device Emits Odor; Device Emits Odor
THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A 4057 ERROR CODE AND WAS EMITTING A BURNING SMELL. NO FIRE OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11642447 ↗MalfunctionDec 4, 2020Device Emits Odor; Smoking; Device Emits Odor; Smoking
THE CUSTOMER REPORTED THAT THE PICCOLO XPRESS CHEMISTRY ANALYZER EMITTED A BURNING ODOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10946047 ↗MalfunctionNov 24, 2020Device Emits Odor; Smoking; Device Emits Odor; Smoking
THE CUSTOMER REPORTED SMOKE COMING FROM THE DEVICE WHERE THE PRINTER IS. A BURNING SMELL WAS OBSERVED AFTER POWERING ON THE DEVICE. IT WAS ALSO REPORTED THAT ASH WAS FOUND ON THE TABLE NEXT TO THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10898494 ↗MalfunctionNov 3, 2020Labelling, Instructions for Use or Training Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Inaccurate Information
THE CUSTOMER REPORTED A DISCREPANCY FOUND WITH THE INFORMATION INDICATED IN THE PACKAGING INSERT FOR THE COMPREHENSIVE METABOLIC PANEL (DOCUMENT NUMBER: (B)(4)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10779159 ↗MalfunctionJul 13, 2020Device Emits Odor; No Device Output; Device Emits Odor; No Device Output
THE CUSTOMER REPORTED THAT THE DEVICE IS EMITTING A BURNING SMELL AND THAT THE DISPLAY "FREEZES".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10268096 ↗MalfunctionJun 19, 2020Device Emits Odor; Device Emits Odor
THE CUSTOMER LAB REPORTED A SMOKE SMELL COMING FROM THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10176924 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K934592. One submission often covers many models, so check the product and lot details in each record.
- Z-2361-2020 · Dec 11, 2019 · TerminatedPiccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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