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Dimension Vista® Flex® reagent cartridge CSA 10445139

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

2 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 Number00842768015144 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1647-2014 FDA Class II initiated 19 Mar 2014

    A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C

    • Terminated Z-0818-2014 FDA Class II initiated 5 Dec 2013

    Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dimension Vista® Flex® reagent cartridge CSA
Generic Name
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
10445139, K4089
Primary DI / UDI-DI
00842768015144
510(k) Number
FDA Product Code
MKW
GMDN Term
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
862.1235
GUDID distribution status
Not in Commercial Distribution

Other devices from Siemens Healthcare Diagnostics Inc.

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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