Recall Z-1790-2014
Roche Diagnostics Operations, Inc. · initiated May 21, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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.
Codes / lots: 1305-31, 1305-21, 1305-22, 1308-35, 1308-36, 130833, 130834, 1308-44, 1310-20, 1418-12, 1307-33, 1421-11, 1417-20, 1423-16, 143115, 1428-07, 1430-16, 1430-17, 1423-15, 1429-15, 1305-40, 1541-05, 1539-15, 1548-15, 1544-11, 1431-14, 1548-17, 1545-03, 1547-20, 1557-12, 1544-06, 1548-08, 1429-13, 1303-31, 1303-32, 1556-16, 1549-04, 1548-16, 1540-20, 1538-10, 1563-06, 1556-17, 1539-13, 1539-14, 1571-12, 1572-19, 1684-05, 1570-14, 1571-13, 1679-13, 1684-06, 1683-17, 1570-17, 1684-07, 1684-08, 1685-16, 1572-20, 1673-01, 1691-17, 1691-19, 1691-18, 1698-05, 1698-06, 1691-14, 1728-10, 1694-19, 1711-17, 1708-20, 1709-03, 1601-01, 1698-03, 1601-03, 1705-20, 1714-18, 1714-19, 1847-02, 1686-01, 1733-17, 1733-19, 1733-16, 1736-06, 1843-02, 1570-15, 1849-01, 1855-15, 1857-22, 1860-10, 1691-20, 1696-05, 1567-01, 1860-24, 1853-02, 1855-10, 1855-11, 1858-02, 1858-03, 1860-12, 1860-13, 1860-14, 1736-04, 1849-02, 1853-01, 1860-11, 1857-23, 1857-24, 1739-19, 1857-25, 1857-26, 1861-18, 1861-19, 1861-23, 1853-03, 1860-16, 1860-23, 1860-15, 1864-16, 1860-19, 1985-13, 1989-19, 1996-02, 1861-20, 1865-19, 1307-34, 1992-19, 1999-16, 1999-17, 1864-19, 1980-15, 1535-09, 1999-20, 1993-01, 1996-01, 1999-18…
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.
FDA-determined cause: Labeling design
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.
Details
- Recall number
- Z-1790-2014
- Initiated
- May 21, 2014
- Posted by FDA
- June 14, 2014
- Terminated
- June 4, 2015
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 462
- Distribution
- US Nationwide Distribution
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1791-2014 Class II | cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat.…Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant… | 05/21/2014Terminated |
| Z-1792-2014 Class II | cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No…Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant… | 05/21/2014Terminated |