Power ExpressRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590672324), received between Sep 1, 2021 and Sep 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K140496); 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

Recent adverse event reports

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

• MalfunctionSep 1, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTED THAT A STAT RACK IN BAY 7 OF DYNAMIC INLET WAS MISIDENTIFIED AS CENTRIFUGE BYPASS RACK IN POWER EXPRESS SYSTEM. AS A RESULT, THREE SAMPLE TUBES WERE ROUTED ON THE LINE AND WERE SORTED TO THE CONNECTED INSTRUMENTS WHICH GENERATED RESULTS, VALIDATED, AND HOSTED TO LIS (LABORATORY INFORMATION SYSTEM). THE UNCENTRIFUGED SAMPLE ROUTED TO DXC 800 INSTRUMENT. THE CUSTOMER REPORTED RECEIVING ERRONEOUS PATIENT RESULTS FOR MULTIPLE ANALYTES FOR THE CMP (COMPREHENSIVE METABOLIC PROFILE). THE SAMPLE WAS WHOLE BLOOD AND AN ERRONEOUS RESULTS WERE GENERATED FOR NA (SODIUM), K (POTASSIUM), CL (CHLORIDE), CO2 (CARBON DIOXIDE), BUN (BLOOD UREA NITROGEN), GLU (GLUCOSE), CREA (CREATININE), CALC (CALCIUM), TP (TOTAL PROTEIN), ALB (ALBUMIN), TBIL (TOTAL BILIRUBIN), TRIG (TRIGLYCERIDES), CHOLESTEROL ALP (ALKALINE PHOSPHATASE), ALT (ALANINE AMINOTRANSFERASE) AND AST (ASPARTATE AMINOTRANSFERASE). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140496. One submission often covers many models, so check the product and lot details in each record.

• Z-2978-2024 · Jul 17, 2024 · Open, Classified
  Power Express, REF B90918
• Z-2980-2024 · Jul 17, 2024 · Open, Classified
  PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
• Z-2979-2024 · Jul 17, 2024 · Open, Classified
  PE Centrifuge, REF: B36365, a component of the Power Express
• Z-1741-2020 · May 17, 2019 · Terminated
  Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.