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Dimension Vista® ECREA CAL 10464578

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842768025419 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

5 recalls · FDA

    • Terminated Z-2285-2020 FDA Class II initiated 4 May 2020 on shared 510(k) K090330

    The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

    • Terminated Z-1233-2020 FDA Class II initiated 18 Dec 2019 on shared 510(k) K090330

    There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

    • Terminated Z-1664-2016 FDA Class II initiated 17 Mar 2016 on shared 510(k) K090330

    Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

    • Terminated Z-2154-2011 FDA Unclassified (pre-2012) initiated 10 Jun 2010 on shared 510(k) K090330

    Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.

    • Terminated Z-2419-2010 FDA Unclassified (pre-2012) initiated 12 Feb 2010 on shared 510(k) K090330

    The ECREA test results may be falsely elevated or depressed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dimension Vista® ECREA CAL
Generic Name
Creatinine IVD, calibrator
Model / Ref / Catalog
10464578, KC270
Primary DI / UDI-DI
00842768025419
510(k) Number
FDA Product Code
JIT
GMDN Term
Creatinine IVD, calibrator
Device Class
Class II
Regulation Number
862.1150
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K090330)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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