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Dimension Vista® CHEM 1 CAL 10716281

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

Recall on shared 510(k) K140790; other models may be affected

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 Number00630414948508 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0767-2025 FDA Class II initiated 12 Nov 2024 on shared 510(k) K140790

    Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out

    • Ongoing Z-0830-2022 FDA Class II initiated 28 Jan 2022 on shared 510(k) K140790

    Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.

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  • Withdrawn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® CHEM 1 CAL
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / Ref / Catalog
10716281, KC110B
Primary DI / UDI-DI
00630414948508
510(k) Number
FDA Product Code
JIX
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class II
Regulation Number
862.1150
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K140790)

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