PK7400 B53299Recalls & reported problems
Beckman Coulter, Inc. · PK7400 Automated Microplate System · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14987666543344), received between Jan 28, 2025 and Jan 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED THE PK7400 PART NUMBER (PN) B53299 SERIAL NUMBER (B)(6) HAD QUESTIONABLE FUZZY CYTOMEGALOVIRUS (CMV) RESULTS FOR SAMPLE ID (B)(6) ON (B)(6) 2025 AND THE FRONT AND BACK CONTROLS FOR CMV. THE IMAGES WERE FUZZY WITH CMV+ RESULTS. REPEAT RESULTS WERE NOT PROVIDED. SERVICE WAS NOT DISPATCHED. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER OVER THE PHONE. CUSTOMER INDICATED THE ISSUE HAS BEEN RESOLVED WITH THE PROVIDED PHONE TROUBLESHOOTING. CUSTOMER INDICATED NO ISSUE WITH OTHER ASSAYS ON THE SAME PK7400. CUSTOMER REQUIRED NO FURTHER ASSISTANCE. THERE WAS NO REPORT OF DEATH OR INJURY IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21253897 ↗MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED THE PK7400 PART NUMBER (PN) B53299 SERIAL NUMBER (B)(6) HAD QUESTIONABLE FUZZY CYTOMEGALOVIRUS (CMV) RESULT FOR SAMPLE ID (B)(6) ON (B)(6) 2024. CUSTOMER PROVIDED IMAGES OF SAMPLE ID (B)(6) AND THE FRONT AND BACK CONTROLS FOR CMV. THE IMAGES WERE FUZZY WITH CMV+ RESULTS. REPEAT RESULTS WERE NOT PROVIDED. SERVICE WAS NOT DISPATCHED. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER OVER THE PHONE. CUSTOMER INDICATED THE ISSUE HAS BEEN RESOLVED WITH THE PROVIDED PHONE TROUBLESHOOTING. CUSTOMER INDICATED NO ISSUE WITH OTHER ASSAYS ON THE SAME PK7400. CUSTOMER REQUIRED NO FURTHER ASSISTANCE. THERE WAS NO REPORT OF DEATH OR INJURY IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21253878 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.