Z-1268-2018 Class II Terminated
FDA device recall Z-1268-2018 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 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
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Reason for Recall
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Distribution Pattern
US Nationwide
Code Information
None