Z-1233-2016 Class II Terminated
FDA device recall Z-1233-2016 was initiated by Roche Diagnostics Operations, Inc. on Feb 23, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 11, 2018). Affected quantity: 35 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2016
- Initiation Date
- Feb 23, 2016
- Termination Date
- Jan 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 Units
Product Description
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Reason for Recall
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.
Distribution Pattern
US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Code Information
Part numbers:05083435001 and 06268854001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1233-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026