Recall Z-1270-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
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).
| Date | Dec 18, 2017 |
| Status | Terminated |
| Reason | Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters. |
| Root cause | Labeling False and Misleading |
| Action | Roche Diagnostics Corporation issued Urgent Medical Device Correction (UMDC) notices and Fax Forms to their customers dated 12/18/2017 via UPS Ground (receipt required). Customers are encouraged to do the following Mandatory Steps to improve the vertical alignment and handling of 13 mm sample tubes and false bottom tubes: FOR cobas e 411 & cobas e 601 analyzers and MODULAR ANALYTICS E 170 module: 1) Always use Roche rack cup adapters with 13 mm tubes 2) Ensure sample tubes are straight FOR cobas e 411 disk system: 1) Always use 13 mm Sample Disk Tube Adapters (SDTAs) with 13 mm sample tube |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.