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UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter) D30863

by Beckman Coulter, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15099590807696 UDI-DI Date19 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2573-2025 FDA Class II initiated 13 Aug 2025
    • Ongoing Z-2572-2025 FDA Class II initiated 13 Aug 2025

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)
Generic Name
Haematological cell analyser IVD
Model / Ref / Catalog
D30863
Primary DI / UDI-DI
15099590807696
510(k) Number
FDA Product Code
GKZ
GMDN Term
Haematological cell analyser IVD
Device Class
Class II
Regulation Number
864.5220
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K240252)

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No