FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
- Recall number
- Z-0752-2021
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
- Status
- Terminated
- Initiated
- 2020-11-23
- Posted
- not on file
- Terminated
- 2023-07-06
- Reason
- During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
- Root cause
- Device Design
- Action
- On 11/20/2020, Roche issued Urgent Medical Device Correction notices to customers via phone and fax. Customers were advised to do the following: A Roche Customer Support Center representative will contact the four affected customers by phone and a copy of UMDC TP-01155 will be faxed to the customer. Any customer questions or concerns will be addressed during the phone call.
- Quantity
- 152 kits and 7 units
- Distribution
- Domestic: IL, FL, GA, WV
- Lot, serial or model codes
- Catalog Number 08445605190 08445567190 08253153190 08058580190
- 510(k) numbers
- ["K191899"]
- 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