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ADVIA® Chemistry LITH Lithium Reagents 10312850

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 Number00630414509778 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

6 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0105-2023 FDA Class II initiated 19 Sep 2022
    • Ongoing Z-0104-2023 FDA Class II initiated 19 Sep 2022

    Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

    • Ongoing Z-0931-2022 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.

    • Terminated Z-2430-2020 FDA Class II initiated 5 Jun 2020

    Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

    • Terminated Z-0589-2017 FDA Class II initiated 7 Oct 2016 on shared 510(k) K050374

    Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement.

    • Terminated Z-0365-2014 FDA Class II initiated 24 Sep 2013 on shared 510(k) K050374

    Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of

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 LITH Lithium Reagents
Generic Name
Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Model / Ref / Catalog
10312850, 141230
Description
Lithium - ADVIA Chem. - RGT - 2x100 tests
Primary DI / UDI-DI
00630414509778
510(k) Number
FDA Product Code
NDW
GMDN Term
Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Device Class
Class II
Regulation Number
862.3560
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K050374)

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