FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
- Recall number
- Z-1233-2016
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
- Status
- Terminated
- Initiated
- 2016-02-23
- Posted
- not on file
- Terminated
- 2018-01-11
- Reason
- Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
- Root cause
- Software design
- Action
- Roche Diagnostics sent an "Urgent Medical Device Correction" letter via UPS Ground (receipt required) on February 23, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To prevent this malfunction, a software patch has been developed and validated. The installation of this software patch is mandatory and will be performed by a Roche Field Engineering Specialist (FES). Your Roche FES will contact you to schedule the installation of the software patch. Until the software patch is implemented, Roche recommends that instrument operators monitor their systems for the occurrence of Error 140 Gripper has lost tube. If this error occurs, all components in contact with a spill must have extra cleaning. Refer to the cobas p 512 pre-analytical instrument Operators Manual Version 1.5. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 for further questions.
- Quantity
- 35 Units
- Distribution
- US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
- Lot, serial or model codes
- Part numbers:05083435001 and 06268854001
- 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