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Atellica CH Amylase 11097603

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K991576; other models may be affected

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 Number00630414596389 UDI-DI Date21 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1498-2022 FDA Class II initiated 28 Jun 2022 on shared 510(k) K991576

    Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

    • Terminated Z-2062-2018 FDA Class II initiated 27 Mar 2018 on shared 510(k) K991576

    Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

    • Terminated Z-1658-2016 FDA Class II initiated 17 Mar 2016 on shared 510(k) K991576

    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

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  • Withdrawn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 Amylase
Generic Name
Total amylase IVD, kit, spectrophotometry
Model / Ref / Catalog
11097603
Primary DI / UDI-DI
00630414596389
510(k) Number
FDA Product Code
KHM
GMDN Term
Total amylase IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1070
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K991576)

Show all (12)

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