UniCel DxH 690T Coulter Cellular Analysis System C34520Recalls & reported problems
Beckman Coulter, Inc. · DxH 690T Hematology Analyzer, DxH 690T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590729110), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 13, 2025Class IIOpen, Classified
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Z-2573-2025 · Root cause: Component change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionJul 15, 2021Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT THE POWER STRIP WHERE THE DXH690T HEMATOLOGY INSTRUMENT WAS PLUGGED OVERLOADED AND GENERATED SPARKS. THE FIRE DEPARTMENT WAS CALLED AND THE LABORATORY EVACUATED. THERE WAS NO INDICATION OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY. NO REPORTED CHANGE OR EFFECT ON PATIENT TREATMENT. THERE WAS NEITHER DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172832 ↗
Other Counter, Differential Cell devices
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- CELL-DYN 08H67-01Abbott Laboratories · Counter, differential cell6 recalls269 reports
- Alinity 09P6801Abbott Laboratories · Counter, differential cell2 recalls96 reports
- FACSCanto 338960Becton, Dickinson And Company · Counter, differential cell1 recall117 reports
- Cytomics FC500 UPS (MPL)Beckman Coulter, Inc. · Counter, Differential Cell141 reports
- CELL-DYN 08H00-01Abbott Laboratories · Counter, differential cell1 recall90 reports
- CELL-DYN 09H39-01Abbott Laboratories · Counter, differential cell123 reports
- BD Multitest 662995Becton, Dickinson And Company · Counter, differential cell2 recalls1 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 · each recall links to the FDA recall notice
- 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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