Piccolo Comprehensive Metabolic Panel 400-0028Recalls & reported problems
Abaxis, Inc. · The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI EABA40000281), received between Dec 13, 2019 and Sep 27, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “High Readings” (3 reports).
5 other recalls cover devices cleared under the same FDA submission (K010670, K934592, K942782, K950164, K992140, K993211); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- High Readings3
- Low Readings3
- Device Contamination with Body Fluid1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- Electrolyte Imbalance1
- Hematuria1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024High Readings; High Readings
(B)(6) 2024: ZOETIS ABAXIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A LABORATORY HEALTH PROFESSIONAL REPORTING HIGH POTASSIUM (K+) USING THE COMPREHENSIVE METABOLIC PANEL (CMP) LOT 4251AC2 ON THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(6). THE PATIENT WAS TREATED AND ADMITTED TO THE HOSPITAL FOR HYPERKALEMIA AND RHABDOMYOLYSIS.
Patient problems: Electrolyte Imbalance; Hematuria
MAUDE report 20323498 ↗MalfunctionSep 12, 2024Low Readings; Low Readings
ON 15 AUGUST 2024, ZOETIS ABAXIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A HEALTHCARE PROFESSIONAL REPORTING AN UNEXPECTED HIGH POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER, SERIAL NUMBER (B)(6), AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP), LOT 4251AC2. THE PATIENT, A 21-YEAR-OLD MALE, WAS TREATED BASED ON THE RESULTS OF THE PICCOLO XPRESS CHEMISTRY ANALYZER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207488 ↗MalfunctionApr 30, 2024Low Readings; Low Readings
18 APR 2024: ABAXIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A LABORATORY HEALTH PROFESSIONAL REPORTING LOW POTASSIUM (K+) USING THE COMPREHENSIVE METABOLIC PANEL (CMP) ON THE PICCOLO XPRESS ANALYZER. THE PATIENT WAS TREATED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19216258 ↗MalfunctionNov 23, 2022High Readings; High Readings
A LABORATORY HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED HIGH CREATININE (CRE) RESULTS. PER REPORT, A PATIENT WAS TREATED BASED ON SYMPTOMS OF APPENDICITIS - NOT DUE TO THE PICCOLO XPRESS ANALYZER RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15854127 ↗MalfunctionJun 14, 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 SODIUM (NA+). THE PATIENT WAS TREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14686943 ↗MalfunctionMar 20, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid
CUSTOMER SAYS THEY RECEIVED REAGENT DISCS THAT APPEAR ALREADY USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9862762 ↗MalfunctionDec 13, 2019Low Readings; Low Readings
LOW POTASSIUM (K+) PATIENT RESULTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9469240 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K010670, K934592, K942782, K950164, K992140, K993211. 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)
- Z-1066-2011 · Nov 19, 2010 · TerminatedAbaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; Product is
- Z-1155-2010 · Nov 16, 2009 · TerminatedPiccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufa
- Z-2287-2008 · Apr 21, 2008 · TerminatedPiccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-c
- Z-2286-2008 · Apr 21, 2008 · TerminatedPiccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a s
Other Mercuric Thiocyanate, Colorimetry, Chloride devices
- Piccolo MetLyte 8 Panel 400-0023Abaxis, Inc. · Mercuric Thiocyanate, Colorimetry, Chloride1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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