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Atellica CH A1c_3 Calibrator 11099328

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00630414597300 UDI-DI Date22 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2643-2014 FDA Class II initiated 6 Aug 2014

    The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.

    • Terminated Z-2135-2013 FDA Class II initiated 30 Jul 2013 on shared 510(k) K081895

    Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..

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  • Withdrawn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
Atellica CH A1c_3 Calibrator
Generic Name
Glycated haemoglobin (HbA1c) IVD, calibrator
Model / Ref / Catalog
11099328
Primary DI / UDI-DI
00630414597300
510(k) Number
FDA Product Code
JIX
GMDN Term
Glycated haemoglobin (HbA1c) IVD, calibrator
Device Class
Class II
Regulation Number
862.1150
GUDID distribution status
Not in Commercial Distribution

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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