Piccolo General Chemistry 13 400-0029Recalls & reported problems
Abaxis, Inc. · The Piccolo® General Chemistry 13 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), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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 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 EABA40000291), received between Jun 11, 2024 and Jun 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (1 report).
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
- Component Misassembled1
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.
MalfunctionJun 11, 2024Component Misassembled; Component Misassembled
13 MAY 2024: ABAXIS GRIESHEIM, TECHNICAL SUPPORT RECEIVED AN EMAIL FROM A DISTRIBUTOR WITH THE FOLLOWING REPORT: THE CUSTOMER REPORTED OPENING SECONDARY PACKAGING FOR THE GENERAL CHEMISTRY 13 PANEL LOT 4065AB8. THE CUSTOMER LOADED THE PANEL FOR USE IN THE PICCOLO XPRESS ANALYZER. THE PICCOLO XPRESS ANALYZER PROVIDES A PRINTOUT OF THE RESULTS ONCE THE PANEL HAS BEEN PROCESSED. THE CUSTOMER STATED THE PRINTOUT READ COMPREHENSIVE METABOLIC LOT 4065AC1. IT WAS CONFIRMED THE PATIENT WAS NOT IMPACTED AND THE REPORTED ISSUE DID NOT CONTRIBUTE TO SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510349 ↗
Other Nadh Oxidation/Nad Reduction, Ast/Sgot devices
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 20764949322Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot6 reports
- Aspartate Aminotransferase acc. to IFCC II 08104719190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot5 reports
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 5850819190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot4 reports
- Aspartate Aminosransferase acc. to IFCC with pyridoxal phosphate activation 08056838190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot4 reports
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation 4467493190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot3 reports
- Piccolo AmLyte 13 400-0041Abaxis, Inc. · Nadh Oxidation/Nad Reduction, Ast/Sgot1 report
- ARCHITECT 7D81-22Abbott GmbH · Nadh oxidation/nad reduction, ast/sgot1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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