FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
- Recall number
- Z-0168-2014
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
- Status
- Terminated
- Initiated
- 2013-09-16
- Posted
- 2013-11-05
- Terminated
- 2015-05-12
- Reason
- 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
- Root cause
- Software Design Change
- Action
- Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded. consignees were asked to complete the attached faxback form and fax it to 1-877-266-0997 and file the Urgent Medical Device Correction (UMDC) for future reference. Question should be directed to Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 For questions regarding thisr ecall call 317-576-3911.
- Quantity
- 527 units
- Distribution
- Nationwide Distribution and Puerto Rico
- Lot, serial or model codes
- software version 9864.C2
- 510(k) numbers
- ["K951595"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28