FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
- Recall number
- Z-0922-2020
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
- Status
- Terminated
- Initiated
- 2019-10-08
- Posted
- not on file
- Terminated
- 2020-10-15
- Reason
- Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
- Root cause
- Software design
- Action
- Roche issued Urgent Medical Device Correction TP-00791 mailed via UPS Ground (receipt required) on 10/8/2019. The letter identifies the problem, health risk and action to take: Complete the attached fax form (TP-00792) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference Roche will resolve this issue in a future software update. In the next couple of weeks, a Roche Representative will be contacting you to adjust alarm code mapping as needed per your specific configuration. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions. The UMDC will also post to the diagnostics.roche.com website
- Quantity
- 20
- Distribution
- US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
- Lot, serial or model codes
- Cobas infinity software version 2.4.1 through 2.5.4
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- 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