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Dimension Vista® Flex® reagent cartridge NAPA 10445131

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

4 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 Number00842768015342 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

    • Terminated Z-2182-2018 FDA Class II initiated 19 Apr 2018 on shared 510(k) K062024

    The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 g/mL [5.4 mol/L].

    • Terminated Z-2181-2018 FDA Class II initiated 19 Apr 2018 on shared 510(k) K062024

    The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.

    • Terminated Z-0408-2013 FDA Class II initiated 9 Aug 2012 on shared 510(k) K062024

    Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.

    • Terminated Z-1739-2011 FDA Unclassified (pre-2012) initiated 30 Nov 2010 on shared 510(k) K062024

    False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: ASL, B2MIC, B2MU, CRP,CYSC, HCYS, hcCRP, IGE, IGG3, IGG4, RF, and STFR resulting in inappropriate patient treatment.

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 NAPA
Generic Name
N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10445131, K4111
Primary DI / UDI-DI
00842768015342
510(k) Number
FDA Product Code
LAN
GMDN Term
N-acetyl procainamide (NAPA) 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 (K062024)

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