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Dimension Vista® Flex® reagent cartridge PROC 10445130

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

7 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 Number00842768015403 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

7 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1660-2018 FDA Class II initiated 29 Jun 2017 on shared 510(k) K061655
    • Terminated Z-1658-2018 FDA Class II initiated 29 Jun 2017 on shared 510(k) K061655

    Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

  • 2 recalls, same reason

    • Terminated Z-1666-2016 FDA Class II initiated 17 Mar 2016 on shared 510(k) K061655
    • Terminated Z-1665-2016 FDA Class II initiated 17 Mar 2016 on shared 510(k) K061655

    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-0339-2016 FDA Class II initiated 30 Sep 2015 on shared 510(k) K061655

    Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.

    • Terminated Z-2175-2012 FDA Class III initiated 17 Jul 2012 on shared 510(k) K061655

    Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

    • Terminated Z-1433-2012 FDA Not yet classified initiated 17 Feb 2012 on shared 510(k) K061655

    Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium

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® Flex® reagent cartridge PROC
Generic Name
Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10445130, K4110
Primary DI / UDI-DI
00842768015403
510(k) Number
FDA Product Code
LAR
GMDN Term
Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
862.3320
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K061655)

Show all (12)

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