Recall Z-1792-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
| Date | Jun 14, 2014 (initiated May 21, 2014) |
| Status | Terminated |
| Reason | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. |
| Root cause | Labeling design |
| Action | Roche sent an Urgent Medical Device Correction (UMDC) letter dated May 20, 2014 via UPS Grount (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Follow the instructions in the Precautions Regarding Handling the Aspiration Tube Filter section in this UMDC; 2. Discontinue performing ProCell/Clean Cell aspiration tube filter check as this maintenance item will be performed by your Roche FSR as a part of service maintenance; 3. If you have distributed the products listed within this UMDC t |
| Quantity | 149 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060373 | COBAS 6000 SERIES SYSTEM Roche Diagnostics, Mar 13, 2006 |