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Piccolo Renal Function Panel 400-0027Recalls & reported problems

Abaxis, Inc. · The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide 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 1

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 EABA40000271), received between Oct 18, 2019 and Oct 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Readings” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K010670, K022312, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Low Readings1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 18, 2019Low Readings; Low Readings

    LOW POTASSIUM (K+) PATIENT RESULT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9211011 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010670, K022312, 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-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
  • 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

Other Phosphomolybdate (Colorimetric), Inorganic Phosphorus devices

All Phosphomolybdate (Colorimetric), Inorganic Phosphorus devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.