Recall Z-1270-2018— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-12-18, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-18
- Terminated
- 2019-04-09
- Firm location
- Indianapolis, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.