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ADVIA® Chemistry FRUC Reagents 10361941

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

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 Number00630414558073 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

5 recalls · 3 ongoing · FDA

    • Ongoing Z-0930-2022 FDA Class II initiated 9 Feb 2022

    Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

  • 2 recalls, same reason

    • Ongoing Z-0101-2021 FDA Class II initiated 22 Sep 2020 on shared 510(k) K131307
    • Ongoing Z-0102-2021 FDA Class II initiated 22 Sep 2020 on shared 510(k) K131307

    Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

  • 2 recalls, same reason

    • Terminated Z-2281-2020 FDA Class II initiated 4 May 2020
    • Terminated Z-2280-2020 FDA Class II initiated 4 May 2020

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

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  • Withdrawn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
ADVIA® Chemistry FRUC Reagents
Generic Name
Fructosamine IVD, kit, spectrophotometry
Model / Ref / Catalog
10361941, 4862501
Description
Fructosamine - ADVIA Chem. - RGT - 200 tests
Primary DI / UDI-DI
00630414558073
510(k) Number
FDA Product Code
LCP
GMDN Term
Fructosamine IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
864.7470
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K131307)

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