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Creatinine Jaffe Gen.2 09686231190

by Roche Diagnostics Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K951595; 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 Number07613336223185 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-1675-2021 FDA Class II initiated 26 Apr 2021 on shared 510(k) K951595

    Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

    • Terminated Z-0100-2017 FDA Class II initiated 15 Jul 2016 on shared 510(k) K951595

    Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

    • Terminated Z-0168-2014 FDA Class II initiated 16 Sep 2013 on shared 510(k) K951595

    Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof

    • Terminated Z-0696-2013 FDA Class III initiated 19 Nov 2012 on shared 510(k) K951595

    A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access

  • 2 recalls, same reason

    • Terminated Z-0007-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008 on shared 510(k) K951595
    • Terminated Z-0012-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008

    Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

    • Terminated Z-0667-03 FDA Unclassified (pre-2012) initiated 13 Feb 2003 on shared 510(k) K951595

    After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.

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
Creatinine Jaffe Gen.2
Generic Name
Creatinine IVD, kit, spectrophotometry
Model / Ref / Catalog
09686231190
Primary DI / UDI-DI
07613336223185
510(k) Number
FDA Product Code
CGX
GMDN Term
Creatinine IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1225
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K951595)

Show all (12)

Other devices from Roche Diagnostics Corp.

See all devices from Roche Diagnostics Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No