Z-1270-2018 Class II Terminated
FDA device recall Z-1270-2018 was initiated by Roche Diagnostics Corporation on December 18, 2017 and is designated Class II. Reason for recall: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters. The recall status is terminated (terminated April 9, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- December 18, 2017
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
Reason for Recall
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Distribution Pattern
US Nationwide
Code Information
None