FDA Device recall Z-1233-2016
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1233-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-23 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | AZ, GA, MI, OH, PR, TN, TX, WA |
Product
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
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.
Identifiers
| code_info | Part numbers:05083435001 and 06268854001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2016%22
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