Z-1090-2017 Class II Terminated
FDA device recall Z-1090-2017 was initiated by Roche Diagnostics Corporation on Dec 27, 2016 and is designated Class II. The recall status is terminated (terminated Aug 4, 2017). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 1, 2017
- Initiation Date
- Dec 27, 2016
- Termination Date
- Aug 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Distribution Pattern
TX and WA
Code Information
Serial Number 63004316 63004416 63004516 63002816 63002916
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1090-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026