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Atellica IM BR MCM 10995479

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

Recall on shared 510(k) K982680; 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 Number00630414598062 UDI-DI Date27 Dec 2017ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2425-2021 FDA Class II initiated 6 Jul 2021 on shared 510(k) K982680
    • Ongoing Z-2426-2021 FDA Class II initiated 6 Jul 2021 on shared 510(k) K982680
    • Ongoing Z-2424-2021 FDA Class II initiated 6 Jul 2021 on shared 510(k) K982680

    Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

  • 3 recalls, same reason

    • Terminated Z-1748-2017 FDA Class II initiated 8 Mar 2017 on shared 510(k) K982680
    • Terminated Z-1747-2017 FDA Class II initiated 8 Mar 2017 on shared 510(k) K982680
    • Terminated Z-1749-2017 FDA Class II initiated 8 Mar 2017 on shared 510(k) K982680

    Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems

  • 2 recalls, same reason

    • Terminated Z-0507-2013 FDA Class II initiated 14 Nov 2012 on shared 510(k) K982680
    • Terminated Z-0512-2013 FDA Class II initiated 14 Nov 2012 on shared 510(k) K982680

    Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

    • Terminated Z-0162-2013 FDA Class II initiated 11 Sep 2012 on shared 510(k) K982680

    BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

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  • Withdrawn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 IM BR MCM
Generic Name
Cancer antigen 27-29 (CA27-29) IVD, control
Model / Ref / Catalog
10995479
Primary DI / UDI-DI
00630414598062
510(k) Number
FDA Product Code
JJX
GMDN Term
Cancer antigen 27-29 (CA27-29) IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cancer antigen 27-29 (CA27-29) IVD, control

Cleared under the same submission (K982680)

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