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Piccolo AmLyte 13 400-0041Recalls & reported problems

Abaxis, Inc. · The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI EABA40000411), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K091052, 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 18, 2026.

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1
  • Low Readings1
  • Output Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem

    THE CUSTOMER, REPORTED UNEXPECTED LOW CREATININE(CRE). THE PATIENT WAS NOT TREATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15089468 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091052, 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 · Terminated
    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
  • Z-1066-2011 · Nov 19, 2010 · Terminated
    Abaxis 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 · Terminated
    Piccolo 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 · Terminated
    Piccolo 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 · Terminated
    Piccolo 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

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Sources and updates

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