PK7300 N3209000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14987666535721), received between Feb 2, 2018 and Aug 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Defective Component; Defective Component

  BECKMAN FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM), THE FSE HAD POWERED UP THE SYSTEM AFTER REPLACING PM PARTS AND WENT OUT FOR A BREAK WHILE SYSTEM INITIALIZED. THE CUSTOMER CALLED FSE AND REPORTED INSTRUMENT SPARKING AND OBSERVED FLAMES. AN OPEN FLAME AND SPARK OCCURRED FROM THE BACK LEFT SIDE OF THE ANALYZER. NO ONE WAS INJURED BUT FIRE EXTINGUISHER WAS DISCHARGED BY THE CUSTOMER. BUILDING WAS EVACUATED AND FIRE DEPARTMENT WAS CALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379069 ↗
• MalfunctionApr 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS/QUESTIONED RESULTS WITH O FLAGS ON THEIR PK7300 ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY OR IMPACT TO PATIENT CARE ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653680 ↗
• MalfunctionFeb 2, 2018Sparking; Sparking

  THE CUSTOMER REPORTED OBTAINING MULTIPLE ERROR MESSAGES ON THE LABORATORY'S OLYMPUS PK7300 AUTOMATED BLOOD BANK ANALYZER (SERIAL NUMBER (B)(4)). BOTH "REAGENT TRANSFER PITCH MOTOR ERRORS" AND "REAGENT TRANSFER FOR/BACK MOTOR ERRORS" WERE OBTAINED. THERE WAS NO PATIENT SAMPLE INVOLVED IN THIS EVENT, THEREFORE THERE WAS NO CHANGE TO OR IMPACT TO PATIENT TREATMENT IN CONJUNCTION WITH THIS EVENT. A BEC (BECKMAN COULTER) FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S LABORATORY TO ASSESS INSTRUMENT PERFORMANCE.

  Patient problems: No Patient Involvement

  MAUDE report 7235726 ↗