cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-32
FDA device recall Z-1792-2014 · posted 2014-06-14 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
- Action taken
- 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 to other sites or facilities, please provide them with a copy of the UMDC; and 4. Complete the faxback form enclosed with this UMDC and fax it to 1-888-410-6620. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 149
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-05-21
- Date posted
- 2014-06-14
- Date terminated
- 2015-06-04
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS 6000 SERIES SYSTEM (K060373) | Roche Diagnostics | 2006-03-13 |